logiover/fda-data-scraper-sample-data huggingface dataset:
FDA recall D-1572-2020 (Class I, Drugs) — status: Terminated
Recalling firm: SG24 LLC
Address: 8315 Rivoli Road Ste A, Bolingbroke, GA 31004, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004  UPC 793573147125
Quantity: 9600 bottles
Reason for recall: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Distribution: Nationwide
Code info: SKU 051230024  All lots labeled to contain methanol
Recall initiated: 20200814; classified: 20200911; reported: 20200909
Terminated: 20230605
FDA recall D-1325-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Pharm D Solutions, LLC
Address: 1304 S Loop W , Houston, TX 77054-4010, United States
Recall type: FDA Mandated; initial notification: Press Release
Product: Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Quantity: 279 vials
Reason for recall: Lack of Sterility Assurance.
Distribution: Nationwide within the United States
Code info: Lot #: 01082019:88 Exp. 07/06/2019; 03182019:58 Exp. 09/14/2019
Recall initiated: 20190523; classified: 20190607; reported: 20190619
Terminated: 20210205
FDA recall D-0037-2023 (Class II, Drugs) — status: Ongoing
Recalling firm: Pharmacy Plus, Inc. dba Vital Care Compounder
Address: 115 S 40th Ave , Hattiesburg, MS 39402-6600, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS  39402
Quantity: 40 vials
Reason for recall: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Distribution: AL, LA, MS, and TN
Code info: Lot: 55786, BUD: 12/31/2022
Recall initiated: 20221007; classified: 20221102; reported: 20221109
FDA recall D-0452-2023 (Class II, Drugs) — status: Terminated
Recalling firm: Ecometics, Inc.
Address: 19 Concord St , Norwalk, CT 06854-3706, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Reason for recall: CGMP DEVIATIONS
Distribution: Nationwide within the United States
Code info: Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24
Recall initiated: 20230224; classified: 20230308; reported: 20230315
Terminated: 20230621
FDA recall D-0321-2024 (Class III, Drugs) — status: Ongoing
Recalling firm: Teva Pharmaceuticals USA, Inc
Address: 400 Interpace Pkwy Bldg A , Parsippany, NJ 07054-1120, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Quantity: 12,916 cartons
Reason for recall: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Distribution: nationwide
Code info: Lot #: 100042978, Exp 7/31/2024
Recall initiated: 20240125; classified: 20240212; reported: 20240221
Drug details: brand_name: NORTREL
generic_name: NORETHINDRONE AND ETHINYL ESTRADIOL
manufacturer_name: Teva Pharmaceuticals USA, Inc.
product_type: HUMAN PRESCRIPTION DRUG
pharm_class_epc: Estrogen [EPC], Progestin [EPC]
pharm_class_moa: Estrogen Receptor Agonists [MoA]
pharm_class_cs: Progesterone Congeners [CS]
FDA recall D-790-2015 (Class II, Drugs) — status: Terminated
Recalling firm: Attix Pharmaceuticals
Address: 184 Front St E unit 801, Toronto,  N/A, Canada
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: Methyl Folate Calcium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Quantity: 5 grams
Reason for recall: Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Distribution: Nationwide to compounding pharmacies and research organizations.
Code info: All lots repackaged and distributed between 01/05/12 to 02/12/15
Recall initiated: 20141114; classified: 20150420; reported: 20150429
Terminated: 20151007
FDA recall D-0356-2025 (Class II, Drugs) — status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Address: 54/1 Budihal Village , Bengaluru, N/A N/A, India
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Quantity: 4956 vials
Reason for recall: Lack of Assurance of Sterility: Media fill with bacterial contamination
Distribution: U.S. Nationwide
Code info: A240467B, exp. date 07/2026
Recall initiated: 20250321; classified: 20250408; reported: 20250416
Drug details: brand_name: HALOPERIDOL DECANOATE
generic_name: HALOPERIDOL DECANOATE
manufacturer_name: BluePoint Laboratories
product_type: HUMAN PRESCRIPTION DRUG
route: INTRAMUSCULAR
substance_name: HALOPERIDOL DECANOATE
FDA recall D-0960-2020 (Class II, Drugs) — status: Terminated
Recalling firm: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Address: 1990 Westwood Blvd Ste 135 , Los Angeles, CA 90025-4650, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
Reason for recall: Lack of Assurance of Sterility
Distribution: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Code info: Lot #: 10152019+53126, Exp 4/6/2020
Recall initiated: 20200115; classified: 20200305; reported: 20200311
Terminated: 20231207
FDA recall D-1455-2019 (Class II, Drugs) — status: Ongoing
Recalling firm: Teva Pharmaceuticals USA
Address: 400 Interpace Pkwy , Parsippany, NJ 07054-1120, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: LOSARTAN POTASSIUM 50 mg TABLET BULK  90 count bottles and 1000 count bottles, NDC 00591-3746-00
Quantity: 2,924,000 tablets
Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Distribution: Nationwide by 4 major distributors.
Code info: Arrow Malta (Teva) Bulk Product Lot #  1169752A, exp. date 01/2020, 1000 tablets/bottle  1169753A, exp. date 01/2020, 90 tablets/bottle    Golden State Medical Finished Product Lot #  GS017387, exp. date 01/2020  GS017651, exp. date 01/2020  GS017479, exp. date 01/2020
Recall initiated: 20190606; classified: 20190709; reported: 20190717
FDA recall D-0165-2018 (Class II, Drugs) — status: Terminated
Recalling firm: KRS Global Biotechnology, Inc
Address: 791 Park of Commerce Blvd Ste 600 , Boca Raton, FL 33487-3633, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Quantity: 4,530 jars
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Distribution: Nationwide in the USA, Bermuda, and New Zealand
Code info: Lots: 06072017@22 BUD: 12/4/2017; 06222017@30  BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017
Recall initiated: 20171116; classified: 20180108; reported: 20180117
Terminated: 20200511
FDA recall D-0347-2024 (Class II, Drugs) — status: Terminated
Recalling firm: MCKESSON CORPORATION
Address: 6555 NORTH STATE HIGHWA , IRVING, TX 75039, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
Quantity: 42 units
Reason for recall: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Distribution: Nationwide in the US
Code info: Lot: 7001796, Exp 05/31/2025
Recall initiated: 20240212; classified: 20240222; reported: 20240228
Terminated: 20241001
Drug details: brand_name: CABTREO
generic_name: CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE
manufacturer_name: Bausch Health US LLC
product_type: HUMAN PRESCRIPTION DRUG
route: TOPICAL
substance_name: ADAPALENE, BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE
pharm_class_epc: Retinoid [EPC]
pharm_class_cs: Retinoids [CS]
FDA recall D-0081-2026 (Class II, Drugs) — status: Ongoing
Recalling firm: GenoGenix  LLC
Address: 2840 Nw 2nd Ave Ste 204 , Boca Raton, FL 33431-6692, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Reason for recall: Lack of Assurance of Sterility
Distribution: US Nationwide.
Code info: All lots within expiry.
Recall initiated: 20250730; classified: 20251021; reported: 20251015
FDA recall D-0454-2018 (Class II, Drugs) — status: Terminated
Recalling firm: Pharmedium Services, LLC
Address: 150 N Field Dr Ste 350 , Lake Forest, IL 60045-2506, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Glycopyrrolate in all strengths, all doses, and all packaging.
Quantity: Unknown
Reason for recall: Lack of sterility assurance.
Distribution: U.S.A. Nationwide
Code info: All lots remaining within expiry.
Recall initiated: 20171227; classified: 20180220; reported: 20180228
Terminated: 20200507
FDA recall D-1027-2017 (Class II, Drugs) — status: Terminated
Recalling firm: SCA Pharmaceuticals
Address: 8821 Knoedl Ct , Little Rock, AR 72205-4600, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Reason for recall: Lack of Assurance of Sterility; product has the potential to leak.
Distribution: Nationwide
Code info: Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017
Recall initiated: 20170714; classified: 20170726; reported: 20170802
Terminated: 20190501
FDA recall D-0435-2021 (Class II, Drugs) — status: Terminated
Recalling firm: Cardinal Health Inc.
Address: 7000 Cardinal Pl , Dublin, OH 43017-1091, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850  Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
Quantity: 664 bottles
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution: FL, GA, SC
Code info: MP0077
Recall initiated: 20210315; classified: 20210524; reported: 20210602
Terminated: 20240617
Drug details: brand_name: XIGDUO
generic_name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
manufacturer_name: AstraZeneca Pharmaceuticals LP
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDE
FDA recall D-0394-2020 (Class II, Drugs) — status: Completed
Recalling firm: Altaire Pharmaceuticals, Inc.
Address: 311 W Ln PO Box 849, Aquebogue, NY 11931-0849, United States
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Reason for recall: Lack of Assurance of Sterility
Distribution: U.S.A. Nationwide
Code info: Lot #: 18229 9/21  18229 9/21  19056 03/22
Recall initiated: 20190702; classified: 20191115; reported: 20191127
FDA recall D-0536-2022 (Class II, Drugs) — status: Terminated
Recalling firm: ULTRAtab Laboratories, Inc.
Address: 50 Toc Dr , Highland, NY 12528-1506, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Quantity: 6,249,082 tablets
Reason for recall: CGMP Deviations
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Code info: Product Codes: L210L  Bulk Lots: 18L120, 19B044, 19E082
Recall initiated: 20220126; classified: 20220209; reported: 20220216
Terminated: 20250107
FDA recall D-662-2013 (Class II, Drugs) — status: Terminated
Recalling firm: Clinical Specialties Compounding Pharmacy
Address: 318 Baston Rd , Augusta, GA 30907, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Quantity: 637ml total
Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution: FL, GA and SC.
Code info: Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.
Recall initiated: 20130320; classified: 20130703; reported: 20130710
Terminated: 20170222
FDA recall D-0314-2021 (Class III, Drugs) — status: Terminated
Recalling firm: Cardinal Health Inc.
Address: 7000 Cardinal Pl , Dublin, OH 43017-1091, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA  19044; NDC 57894-640-01.
Quantity: 48 boxes
Reason for recall: Temperature Abuse
Distribution: AL, LA, MS, TN
Code info: KESOY.AI Exp. 04/2022
Recall initiated: 20210309; classified: 20210329; reported: 20210407
Terminated: 20211104
Drug details: brand_name: TREMFYA
generic_name: GUSELKUMAB
manufacturer_name: Janssen Biotech, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: SUBCUTANEOUS
substance_name: GUSELKUMAB
pharm_class_epc: Interleukin-23 Antagonist [EPC]
pharm_class_moa: Interleukin-23 Antagonists [MoA]
FDA recall D-0580-2019 (Class I, Drugs) — status: Terminated
Recalling firm: King Bio Inc.
Address: 3 Westside Dr , Asheville, NC 28806-2846, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Dr. King's Natural Medicine Homeopathic Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955024224, NDC 57955-0242-2
Quantity: 38 bottles
Reason for recall: Microbial contamination
Distribution: U.S.A. Nationwide, Canada, and Australia.
Code info: Lot Numbers: 041816A Exp. 04/19; 070816E Exp. 07/19
Recall initiated: 20180720; classified: 20190308; reported: 20190320
Terminated: 20220119
FDA recall D-1235-2015 (Class III, Drugs) — status: Terminated
Recalling firm: American Health Packaging
Address: 2550 John Glenn Ave Suite A, Columbus, OH 43217-1188, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons.  Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
Quantity: 341 Cartons
Reason for recall: Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Distribution: U.S. Nationwide
Code info: Lot #:151360, Expiry: 12/31/2016
Recall initiated: 20150626; classified: 20150714; reported: 20150722
Terminated: 20180815
FDA recall D-0796-2018 (Class II, Drugs) — status: Terminated
Recalling firm: Kroger Specialty Pharmacy, Inc.
Address: 100 Pear Orchard Dr Ste A , Vicksburg, MS 39180-7153, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Quantity: Unknown
Reason for recall: Lack of Processing Controls.
Distribution: MS, LA, AR, IL, FL
Code info: All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Recall initiated: 20180403; classified: 20180510; reported: 20180516
Terminated: 20200507
FDA recall D-1245-2019 (Class III, Drugs) — status: Terminated
Recalling firm: LUPIN SOMERSET
Address: 400 Campus Dr , Somerset, NJ 08873-1145, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202  NDC 43386-542-01
Quantity: 10,284 bottles
Reason for recall: Failed Impurities/Degradation Specifications
Distribution: Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Code info: Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020
Recall initiated: 20190410; classified: 20190425; reported: 20190501
Terminated: 20221014
Drug details: brand_name: MORPHINE SULFATE
generic_name: MORPHINE SULFATE
manufacturer_name: Lupin Pharmaceuticals,Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: MORPHINE SULFATE
FDA recall D-1461-2022 (Class II, Drugs) — status: Ongoing
Recalling firm: Family Dollar Stores, Llc.
Address: 500 Volvo Pkwy , Chesapeake, VA 23320-1604, United States
Recall type: Voluntary: Firm initiated; initial notification: Other
Product: QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Quantity: Unknown
Reason for recall: CGMP Deviations: product held outside appropriate storage temperature conditions.
Distribution: Nationwide within the United States
Code info: SKU: 916922
Recall initiated: 20220623; classified: 20220822; reported: 20220831
FDA recall D-509-2013 (Class II, Drugs) — status: Terminated
Recalling firm: TG United, Inc.
Address: 16275 Aviation Loop Dr , Brooksville, FL 34604-6805, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: AMBI 2CPM/15DM/5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Quantity: 355 - 16 ounce bottles
Reason for recall: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Distribution: FL, MS, SC, LA  and TX
Code info: Lot # 12DQ004, Exp. 03/14.
Recall initiated: 20130130; classified: 20130604; reported: 20130612
Terminated: 20160930
FDA recall D-1371-2015 (Class III, Drugs) — status: Terminated
Recalling firm: KVK-Tech, Inc.
Address: 110 Terry Dr , Newtown, PA 18940-3427, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Quantity: 9,696 bottles (100-count), 972 bottles (1000-count)
Reason for recall: Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Distribution: Nationwide
Code info: Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
Recall initiated: 20150714; classified: 20150825; reported: 20150902
Terminated: 20170113
FDA recall D-0666-2018 (Class II, Drugs) — status: Terminated
Recalling firm: Partell Specialty Pharmacy
Address: 5835 S Eastern Ave Ste 101 , Las Vegas, NV 89119-3031, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Testosterone 40 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Reason for recall: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Distribution: NV only
Code info: Lot#: 20171214@90, BUD 06/12/2018; 20171113@81, BUD 05/12/2018; 20180220@58, BUD 08/19/2018.
Recall initiated: 20180322; classified: 20180417; reported: 20180425
Terminated: 20190115
FDA recall D-1130-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Lohxa LLC
Address: 600 Main St Ste 110 , Worcester, MA 01608-2061, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Quantity: 5 boxes  - 250 unit dose cups.
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Distribution: MA, NY and WY
Code info: Lot#:  M030042P, Exp. 01/2020
Recall initiated: 20190325; classified: 20190415; reported: 20190417
Terminated: 20230620
FDA recall D-1222-2016 (Class II, Drugs) — status: Terminated
Recalling firm: Medaus, Inc.
Address: 6801 Cahaba Valley Rd Ste 116 , Birmingham, AL 35242-9609, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: M.I.C B-COMPLEX PREMIX W/HYDROXY B12  W/PRES. (BENZALKONIUM 0.01%)  HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,  B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG,  METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
Quantity: 110 mL in Vials
Reason for recall: Lack of Assurance of Sterility
Distribution: U.S. Nationwide, Japan, and New Zealand.
Code info: Lot #: 160229-24, BUD: 07/25/16,  Lot #: 160315-5, BUD: 07/25/16
Recall initiated: 20160513; classified: 20160708; reported: 20160720
Terminated: 20170616
FDA recall D-1786-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Infusion Options, Inc.
Address: 5924 13th Ave , Brooklyn, NY 11219-4934, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason for recall: Lack of Assurance of Sterility
Distribution: NY only
Code info: All lots within expiry
Recall initiated: 20190612; classified: 20190815; reported: 20190821
Terminated: 20250321