logiover/fda-data-scraper-sample-data huggingface dataset:
FDA recall D-0448-2021 (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: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
Quantity: 96 cartons
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution: FL, GA, SC
Code info: 37674B
Recall initiated: 20210315; classified: 20210524; reported: 20210602
Terminated: 20240617
Drug details: brand_name: BELBUCA
generic_name: BUPRENORPHINE HYDROCHLORIDE
manufacturer_name: BioDelivery Sciences International Inc
product_type: HUMAN PRESCRIPTION DRUG
route: BUCCAL
substance_name: BUPRENORPHINE HYDROCHLORIDE
FDA recall D-0513-2018 (Class II, Drugs) — status: Terminated
Recalling firm: American Pharmaceutical Ingredients LLC
Address: 6650 Highland Rd Ste 302 , Waterford, MI 48327-1665, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Nifedipine USP  for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Quantity: 44500 g
Reason for recall: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Distribution: Nationwide within USA.
Code info: Lot #: a) 020615-2, Exp. 12/04/2018; b)  020615-2, Exp. 12/04/2018; c) 020615-1, Exp. 12/04/2018; d) 020615-1, Exp. 12/04/2018; 020615-2, Exp. 12/04/2018.
Recall initiated: 20180209; classified: 20180222; reported: 20180228
Terminated: 20191202
FDA recall D-871-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Aidapak Services, LLC
Address: 14301 Se 1st St , Vancouver, WA 98684-3501, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.
Quantity: 200 Tablets
Reason for recall: Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs:  VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014;  FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.
Distribution: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code info: FLUCONAZOLE, Tablet, 200 mg has the following codes:   Pedigree: AD65475_16, EXP: 5/28/2014;  Pedigree: W003065, EXP: 6/12/2014.
Recall initiated: 20130702; classified: 20140120; reported: 20140129
Terminated: 20140207
FDA recall D-0375-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Address: 111 S Calvert St Fl 21ST , Baltimore, MD 21202-6174, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Quantity: 287,784 bottles
Reason for recall: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Distribution: Nationwide within the United States
Code info: a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019   b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019;  F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.
Recall initiated: 20190102; classified: 20190115; reported: 20190116
Terminated: 20200626
Drug details: brand_name: CEFDINIR
generic_name: CEFDINIR
manufacturer_name: Lupin Pharmaceuticals, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: CEFDINIR
pharm_class_epc: Cephalosporin Antibacterial [EPC]
pharm_class_cs: Cephalosporins [CS]
FDA recall D-851-2013 (Class II, Drugs) — status: Terminated
Recalling firm: Hospira, Inc.
Address: 600 N Field Dr Bldg J45 , Lake Forest, IL 60045, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Quantity: 340,600 vials
Reason for recall: Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Distribution: Nationwide
Code info: Lot 25394DK, exp. 01/2015
Recall initiated: 20130520; classified: 20130807; reported: 20130814
Terminated: 20141028
Drug details: brand_name: ONDANSETRON
generic_name: ONDANSETRON
manufacturer_name: Hospira, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: INTRAMUSCULAR, INTRAVENOUS
substance_name: ONDANSETRON HYDROCHLORIDE
FDA recall D-0831-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Advanced Pharma Inc.
Address: 9265 Kirby Dr , Houston, TX 77054-2520, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Reason for recall: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Distribution: U.S. Nationwide
Code info: all lots within expiry
Recall initiated: 20170222; classified: 20170523; reported: 20170531
Terminated: 20171018
FDA recall D-241-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Main Street Family Pharmacy, LLC
Address: 126 East Main Street , Newbern, TN 38059, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Quantity: 115 units
Reason for recall: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Distribution: nationwide, specifically:  AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC,   NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV
Code info: all codes distributed prior to and including 05/23/2013
Recall initiated: 20130528; classified: 20131203; reported: 20131211
Terminated: 20140422
FDA recall D-0204-2016 (Class II, Drugs) — status: Terminated
Recalling firm: the Compounder
Address: 340 Marshall Ave Unit 100 , Aurora, IL 60506-5649, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)  : TESTO (Testosterone USP) : DHEA  (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Quantity: 12 (10mL) syringes
Reason for recall: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Distribution: Nationwide
Code info: Lot # 01152015:68@24, Exp 7/14/2015; and  Lot # 02192015:15@12, Exp 8/18/2015
Recall initiated: 20150310; classified: 20151110; reported: 20151118
Terminated: 20160519
FDA recall D-0301-2026 (Class II, Drugs) — status: Ongoing
Recalling firm: Unichem Pharmaceuticals USA Inc.
Address: 1 Tower Center Blvd Ste 2200 , East Brunswick, NJ 08816-1145, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Reason for recall: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Distribution: US Nationwide and PR.
Code info: Lot # GBHL24005A, Exp Date: 09/2026
Recall initiated: 20260121; classified: 20260130; reported: 20260211
Drug details: brand_name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
generic_name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
manufacturer_name: Unichem Pharmaceuticals (USA), Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
pharm_class_pe: Increased Diuresis [PE]
pharm_class_epc: Thiazide Diuretic [EPC]
pharm_class_cs: Thiazides [CS]
FDA recall D-0945-2023 (Class II, Drugs) — status: Terminated
Recalling firm: SCA Pharmaceuticals
Address: 755 Rainbow Rd Ste B , Windsor, CT 06095-1024, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Quantity: 183 bags
Reason for recall: cGMP deviations: due to shipment of rejected units.
Distribution: KY and NJ
Code info: Lot # 1223047134, Use By: 09/21/2023
Recall initiated: 20230720; classified: 20230726; reported: 20230802
Terminated: 20230921
FDA recall D-0509-2024 (Class II, Drugs) — status: Terminated
Recalling firm: Genentech, Inc.
Address: 1 Dna Way Bldg 5 , South San Francisco, CA 94080-4918, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359
Reason for recall: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Distribution: Nationwide within the United States
Code info: Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Recall initiated: 20240520; classified: 20240524; reported: 20240605
Terminated: 20250811
Drug details: brand_name: CATHFLO ACTIVASE
generic_name: ALTEPLASE
manufacturer_name: Genentech, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: INTRAVENOUS
substance_name: ALTEPLASE
FDA recall D-0298-2022 (Class I, Drugs) — status: Terminated
Recalling firm: Aroma Release Technologies Inc
Address: 7026 Discovery Dr , Chattanooga, TN 37416-1692, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
Quantity: 37 55-gallon drums
Reason for recall: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Distribution: Distributed in the states of Texas and New York.
Code info: Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Recall initiated: 20211130; classified: 20211228; reported: 20220105
Terminated: 20240315
FDA recall D-0163-2023 (Class II, Drugs) — status: Ongoing
Recalling firm: Fisher Scientific Co., LLC
Address: 1 Reagent Ln , Fair Lawn, NJ 07410-2802, United States
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Quantity: a) 1077 bottles, b) 52 cases
Reason for recall: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Distribution: Nationwide in the USA
Code info: Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337,  203338, 203335, 203336
Recall initiated: 20230117; classified: 20230118; reported: 20230125
FDA recall D-653-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Aidapak Services, LLC
Address: 14301 Se 1st St , Vancouver, WA 98684-3501, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001
Quantity: 600 Tablets
Reason for recall: Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014;  HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014;  MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014;  MELATONIN, Tablet, 3 mg, NDC
Distribution: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code info: VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet has the following codes    Pedigree: AD73652_19, EXP: 5/30/2014;  Pedigree: W003591, EXP: 6/24/2014;  Pedigree: AD70655_17, EXP: 5/28/2014;  Pedigree: W003361, EXP: 6/19/2014.
Recall initiated: 20130702; classified: 20140116; reported: 20140122
Terminated: 20140207
FDA recall D-1613-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Herbal Doctor Remedies
Address: 497 Cumbre St , Monterey Park, CA 91754-2114, United States
Recall type: Voluntary: Firm initiated; initial notification: N/A
Product: Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Reason for recall: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Distribution: Nationwide within the United States and Brazil and on the internet
Code info: All lots within expiry
Recall initiated: 20190712; classified: 20190802; reported: 20190814
Terminated: 20230613
FDA recall D-0106-2022 (Class II, Drugs) — status: Terminated
Recalling firm: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Address: 2950 Thousand Oaks Dr Ste 25 , San Antonio, TX 78247-3347, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: B COMPLEX INJ CMP-NO B12, NO LIDOCAINE  INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Quantity: 1 vial
Reason for recall: Lack of assurance of sterility
Distribution: United States including Washington, D.C. and Puerto Rico
Code info: Lot: 07192021:91 BUD: 10/17/2021
Recall initiated: 20211012; classified: 20211108; reported: 20211117
Terminated: 20231004
FDA recall D-0709-2019 (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 SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-0188-2
Quantity: 24 bottles
Reason for recall: Microbial contamination
Distribution: U.S.A. Nationwide, Canada, and Australia.
Code info: Lot: 010418D Exp. 01/20
Recall initiated: 20180720; classified: 20190308; reported: 20190320
Terminated: 20220119
FDA recall D-0104-2022 (Class II, Drugs) — status: Terminated
Recalling firm: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Address: 2950 Thousand Oaks Dr Ste 25 , San Antonio, TX 78247-3347, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: ALPROSTADIL 40MCG/ML INJ  40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Quantity: 4 vials
Reason for recall: Lack of assurance of sterility
Distribution: United States including Washington, D.C. and Puerto Rico
Code info: Lot: 06242021:37 BUD: 10/22/2021; 08132021:74 BUD: 12/11/2021; 07132021:94 BUD:10/23/2021
Recall initiated: 20211012; classified: 20211108; reported: 20211117
Terminated: 20231004
FDA recall D-1010-2019 (Class III, Drugs) — status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Address: 111 S Calvert St Fl 21ST , Baltimore, MD 21202-6174, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Quantity: 3,200 bottles
Reason for recall: Defective Container: Repetitive complaints received indicating pump not working.
Distribution: Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
Code info: Lot # K700086, Exp 11/2019
Recall initiated: 20190313; classified: 20190319; reported: 20190327
Terminated: 20200626
Drug details: brand_name: TESTOSTERONE
generic_name: TESTOSTERONE
manufacturer_name: Lupin Pharmaceuticals, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: TOPICAL
substance_name: TESTOSTERONE
pharm_class_epc: Androgen [EPC]
pharm_class_moa: Androgen Receptor Agonists [MoA]
pharm_class_cs: Androstanes [CS]
FDA recall D-1332-2022 (Class II, Drugs) — status: Terminated
Recalling firm: SterRx, LLC
Address: 141 Idaho Ave , Plattsburgh, NY 12903-3987, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY  12903, NDC 70324-327-02.
Quantity: 360 bags
Reason for recall: Lack of Assurance of Sterility
Distribution: Nationwide within the United States
Code info: Lot #: CHL, Exp. Date Dec 29, 2022
Recall initiated: 20220725; classified: 20220809; reported: 20220817
Terminated: 20230622
FDA recall D-0200-2015 (Class II, Drugs) — status: Terminated
Recalling firm: Oregon Compounding Centers, Inc. dba Creative Compounds
Address: 8560 Sw Salish Ln Ste 100 , Wilsonville, OR 97070-9625, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Quantity: 520 mL
Reason for recall: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Distribution: Oregon, Washington
Code info: Lot #: 20140718@1/5, discard date: 1/14/2015;  Lot #: 20140813@25, discard date: 2/9/2015;  Lot #: 20140903@32, discard date: 3/2/2015.
Recall initiated: 20141006; classified: 20141031; reported: 20141112
Terminated: 20150630
FDA recall D-1131-2023 (Class II, Drugs) — status: Terminated
Recalling firm: Central Admixture Pharmacy Services, Inc.
Address: 2200 S 43rd Ave , Phoenix, AZ 85043-3909, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Quantity: 554 bags
Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution: Nationwide in the USA
Code info: Lot# 36-262162, 36-262163, Exp 10/5/2023.              ;
Recall initiated: 20230817; classified: 20230828; reported: 20230906
Terminated: 20250327
FDA recall D-1224-2016 (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 25/50/50 W/PRES. (BENZYL ETOH 2%)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Quantity: 500 mL in Vials
Reason for recall: Lack of Assurance of Sterility
Distribution: U.S. Nationwide, Japan, and New Zealand.
Code info: a) Lot #: 160107-17, BUD: 07/05/16.  b) Lot #: 160107-17, BUD: 07/05/16.
Recall initiated: 20160513; classified: 20160708; reported: 20160720
Terminated: 20170616
FDA recall D-1700-2012 (Class I, Drugs) — status: Terminated
Recalling firm: www.vitaminbestbuy.com
Address: 6001 McKinley Rd. , Brewerton, NY 13029, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Quantity: 52 boxes
Reason for recall: Marketed Without an Approved ANDA/NDA: presence of sibutramine
Distribution: Nationwide
Code info: All lots.
Recall initiated: 20120223; classified: 20120926; reported: 20121003
Terminated: 20181101
FDA recall D-0417-2024 (Class II, Drugs) — status: Terminated
Recalling firm: SCA Pharmaceuticals, LLC
Address: 755 Rainbow Rd Ste B , Windsor, CT 06095-1024, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Quantity: 5,948 syringes, expanded 2,102 syringes
Reason for recall: Lack of Assurance of Sterility
Distribution: Nationwide in the USA
Code info: Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24  Expanded Lot #:  1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024
Recall initiated: 20231109; classified: 20240322; reported: 20240403
Terminated: 20240827
FDA recall D-0702-2021 (Class II, Drugs) — status: Terminated
Recalling firm: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Address: 7802 E Telecom Pkwy , Temple Terrace, FL 33637-0928, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Quantity: 253 syringes
Reason for recall: Lack of sterility assurance
Distribution: FL
Code info: Lot: SUCC10020210624 Exp. 09/22/2021
Recall initiated: 20210730; classified: 20210804; reported: 20210811
Terminated: 20211022