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                Enforcement Reports

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          Enforcement Reports
          Non-Blood Product On-Going RecallsEnforcement Reports Non-Blood Product On-Going Recalls
  
  	
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    PrintFDA's Center for Biologics Evaluation and Research (CBER) is beginning a pilot programintended toexpedite notifications of Non-Blood (HCT/P, Vaccine, Derivative, etc) product recalls that are classified under the Direct Recall Classification (DRC) Program to the public. CBER's DRC Program decreases the resources needed to classify and publish recalls, and allows the reallocation of resources to other agency priorities related to protection of the public health. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be on-going recalls and that have beenclassified as Class I, II or III.These select Non-Blood recalls will be republished with their final classification once the firm's recall is complete. Please send comments or suggestions to CBER_RecallAlerts@fda.hhs.gov.



**For September 13, 2019:**



**CLASSIFICATION**:

Class II



**PRODUCT:**

Kogenate FS antihemophilic factor (recombinant) 2000 IU



**CODE:**

Lots 27118RK & 27119CG



**RECALLING FIRM:**

Bayer HealthCare LLC; Whippany, New Jersey by letter dated July 19, 2019; Firm initiated recall is on-going.



**MANUFACTURER:**

Bayer HealthCare LLC; Berkeley, California



**REASON:**

Some vials from lots 27118RK & 27119CG that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi antihemophilic factor (recombinant) PEGylated-auci 3000 IU.



**VOLUME OF PRODUCT IN COMMERCE:**

2 lots



**DISTRIBUTION PATTERN**:

Nationwide



**For May 6th, 2015:**



CLASSIFICATION:

Class III



PRODUCT:

Sanofi Pasteur’s 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose Vials



CODE:

UI196AA, UI190AC, UI190AD



RECALLING FIRM/MANUFACTURER:

Sanofi Pastuer; Swiftwater, Pennsylvania; by letter dated April 21, 2015; Firm initiated recall is on-going.



REASON:

Three lots of Sanofi Pasteur’s 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed.



VOLUME OF PRODUCT IN COMMERCE:

3 lots



DISTRIBUTION PATTERN:

Nationwide





**For April 29th, 2015:**



CLASSIFICATION:



Class III



PRODUCT:



FLULAVAL QUADRIVALENT

Carton NDC 19515-894-52

Syringe NDC 19515-894-41



CODE:



Product Description
			Carton NDC
			Syringe NDC
			Lot Number
			Exp DateFLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			42N4L
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			5AZ7H
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			ZS95Z
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			A2PK7
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			T3J4S
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			XP4J2
			30-Apr-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			379MY
			31-May-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			AR57J
			31-May-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			2B472
			30-Jun-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			9A3ZM
			30-Jun-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			DR4GF
			30-Jun-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			YF5DT
			30-Jun-15FLULAVAL QUADRIVALENT TF PFS 10s
			19515-894-52
			19515-894-41
			F45C5
			30-Jun-15



RECALLING FIRM/MANUFACTURER:



GlaxoSmithKine;  Saint-Foy, Canada; by letter dated April 14, 2015; Firm initiated recall is on-going.



REASON:



Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.



VOLUME OF PRODUCT IN COMMERCE:



1,689,560 doses were distributed.



DISTRIBUTION PATTERN:



Nationwide

**For December 25th, 2013:**CLASSIFICATION:

Class II

PRODUCT:

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

CODE:

J007354

RECALLING FIRM/MANUFACTURER:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck)

West Point, PA, by letter dated December 20, 2013.Firm initiated recall is ongoing.

REASON:

GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed.

VOLUME OF PRODUCT IN COMMERCE:

1 Lot;(743,360 vials)

DISTRIBUTION PATTERN:

Nationwide, including Puerto Rico

**For December 4th, 2013:**CLASSIFICATION:

Class II

PRODUCT:

MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197Conjugate Vaccine, NDC: 46028-208-01

CODE:

Lot M12115

RECALLING FIRM/MANUFACTURER:

Novartis Vaccines and Diagnostics, Inc; Cambridge, MA; by letter dated December 2, 2013. Firm initiated recall is ongoing.

REASON:

Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197Conjugate Vaccine, with higher-than-specified levels of residual moisture, was distributed.

VOLUME OF PRODUCT IN COMMERCE:

1 Lot ( 8,435 vials)

DISTRIBUTION PATTERN:

Nationwide

**For July 24th, 2013:****CLASSIFICATION:**

Class II

**PRODUCT:**

MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197Conjugate Vaccine,NDC:46028-208-01

**CODE:**

Lot M12118

**RECALLING FIRM/MANUFACTURER:**

Novartis Vaccines and Diagnostics, Inc; Cambridge, MA; by letter dated July 3, 2013. Firm initiated recall is ongoing.

**REASON:**

Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197Conjugate Vaccine, with higher-than-specified levels of residual moisture, was distributed.

**VOLUME OF PRODUCT IN COMMERCE:**

1 Lot (70,170 vials)

**DISTRIBUTION PATTERN:**

Nationwide

**For July 3, 2013:**CLASSIFICATION:

Class II

PRODUCT:

Recombivax HB [Hepatitis B Vaccine (Recombinant)], Adult Formulation, 10ug/mL

CODE:

J001183

RECALLING FIRM/MANUFACTURER:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck)

West Point, PA, by letter dated June 26, 2013.Firm initiated recall is ongoing.

REASON:

Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.

VOLUME OF PRODUCT IN COMMERCE:

1 Lot;(27,020 vials)

DISTRIBUTION PATTERN:

Nationwide

**For December 12, 2012:****CLASSIFICATION:**

Class II

**PRODUCT:**

In-vitro Diagnostic Tests of the following type:

MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515)
	MTS A/B Monoclonal Grouping Cards (Catalog #MTS080017)
	MTS Anti-IgG Cards (Catalog #MTS084024)**CODE:**

07031203730, Expiration 10 Jun 2013; 07031203732, 11 Jun 2013; 07031203734, 12 Jun 2013; 07031203735, 12 Jun 2013; 07031203736, 13 Jun 2013; 09131203702, 17 Jun 2013; 09131203706, 02 Jul 2013
	06061205703, Expiration 13 June 2013
	08071200124, Expiration 07 Jun 2013; 08071200125, 07 Jun 2013; 08071200126, 10 Jun 2013; 08071200127, 10 Jun 2013; 08071200128, 11 Jun 2013; 08071200129, 11 Jun 2013; 08071200130, 13 Jun 2013; 08071200131, 14 Jun 2013; 08071200132, 14 Jun 2013; 08071200133, 17 Jun 2013; 08071200136, 18 Jun 2013; 09061200101, 18 Jun 2013; 09061200103, 19 Jun 2013**RECALLING FIRM/MANUFACTURER:**

Micro Typing Systems, Inc., Pompano Beach, Florida, by letters, dated November 5, 2012.Firm initiated recall is on-going.

**REASON:**

In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed.

**VOLUME OF PRODUCT IN COMMERCE:**

MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515) – 1676 boxes each containing 100 gel cards
	MTS A/B Monoclonal Grouping Cards (Catalog #MTS080017) - 15 boxes each containing 100 gel cards
	MTS Anti-IgG Cards (Catalog #MTS084024) - 3080 boxes each containing 100 gel cards**DISTRIBUTION PATTERN:**

Nationwide and Canada

**For October 25, 2012:****CLASSIFICATION:**

Class III

**PRODUCT:**

Typhim Vi,Typhoid Vi PolysaccharideVaccine

**CODE:**

Lots:E1287-1; E1288-1; G0481-1; G0507-1; G0508-1; G1130-1

**RECALLING FIRM/MANUFACTURER:**

Sanofi Pasteur SA; Marcy L'Etoile, France; by letter dated September24, 2012. Firm initiated recall is ongoing.

**REASON:**

Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.

**VOLUME OF PRODUCT IN COMMERCE:**

E1287-1 (46,156 doses); E1288-1 (104,308 doses); G0481-1 (116,663 doses); G0507-1 (118,606 doses); G0508-1 (118,266 doses); G1130-1 (312,320 doses)

**DISTRIBUTION PATTERN:**

Nationwide

**For August 29, 2012:**CLASSIFICATION:

Class III

PRODUCT:

M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)

CODE:

0851AA

RECALLING FIRM/MANUFACTURER:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

West Point, PA, by letter dated June 12, 2012.Firm initiated recall is ongoing.

REASON:

M-M-R® II Vaccine was inadvertently distributed.

VOLUME OF PRODUCT IN COMMERCE:

1 Batch; 39,000 vials

DISTRIBUTION PATTERN:

Nationwide

                                                                                  Content current as of:
      09/13/2019Enforcement Reports
 
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