Safety
Non-Blood Product On-Going Recalls
FDA's Center for Biologics Evaluation and Research (CBER) is beginning a pilot program intended to expedite 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 been classified 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 December 12, 2012:
CLASSIFICATION:
Class II
PRODUCT:
In-vitro Diagnostic Tests of the following type:
a) MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515)
b) MTS A/B Monoclonal Grouping Cards (Catalog #MTS080017)
c) MTS Anti-IgG Cards (Catalog #MTS084024)
CODE:
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:
b) MTS A/B Monoclonal Grouping Cards (Catalog #MTS080017) - 15 boxes each containing 100 gel cards
c) 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 Polysaccharide Vaccine
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 September 24, 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:
