Trastuzumab Kit containing 1 vial Trastuzumab — Class I drug recall D-135-2013
Terminated recall by Genentech Inc, reported 2013-01-30, distributed nationwide. Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were pac
| Recall number | D-135-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech Inc, South San Francisco, CA, United States |
| Recall initiated | 2012-07-30 |
| Classified | 2013-01-22 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2013-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,140 kits |
| Reason classes | foreign material, specification failure |
| NDC | 50242-0903-69 |
| Lot numbers | 07/14, 08-368-DK-01, 12/14, 454138, 886618 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-135-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.