Recalls / Class I

Class ID-135-2013

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.

Affected lot / code info: Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)

Why it was recalled

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

Recalling firm

Firm: Genentech Inc
Notification channel: E-Mail
Type: Voluntary: Firm initiated
Address: 1 DNA Way, N/A, South San Francisco, California 94080-4990

Distribution

Quantity: 2,140 kits
Distribution pattern: Nationwide

Timeline

Recall initiated: 2012-07-30
FDA classified: 2013-01-22
Posted by FDA: 2013-01-30
Terminated: 2013-03-25
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-135-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.