Non-Blood Product On-Going Recalls
FDA'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 Date
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
42N4L
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
5AZ7H
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
ZS95Z
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
A2PK7
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
T3J4S
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
XP4J2
|
30-Apr-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
379MY
|
31-May-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
AR57J
|
31-May-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
2B472
|
30-Jun-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
9A3ZM
|
30-Jun-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
DR4GF
|
30-Jun-15
|
|
FLULAVAL QUADRIVALENT TF PFS 10s
|
19515-894-52
|
19515-894-41
|
YF5DT
|
30-Jun-15
|
|
FLULAVAL 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-197 Conjugate 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-197 Conjugate 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-197 Conjugate 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-197 Conjugate 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