CLASS I Drug recall · Reported 30 Jan 2013 · FDA Enforcement Report
Trastuzumab Kit containing 1 vial Trastuzumab recalled by Genentech
Genentech is recalling Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg), distributed nationwide in the US. The recall was initiated on 30 Jul 2012 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-135-2013
- FDA event ID
- 63258
- Recalling firm
- Genentech, South San Francisco, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Jul 2012
- FDA classified
- 22 Jan 2013
- Reported
- 30 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2012 | Recall initiated by company | |
| 22 Jan 2013 | Classified by FDA | +176 days |
| 30 Jan 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg) recalled?
Yes. Genentech recalled Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg) on 30 Jul 2012. The recall is Class I and its status is Terminated. Recall number D-135-2013.
Why was it 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.
Which lots are affected?
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)
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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