FDA Drug recall D-135-2013
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg)
- FDA Drug
- Class I
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class I recall of Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg) by Genentech, citing 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 t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-135-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-07-30 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genentech |
| Distribution | US |
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
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.
Identifiers
| 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Genentech
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
FDA Drug · Class II · 2024-06-05 · Genentech - Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill…
FDA Drug · Class III · 2022-11-09 · Genentech - Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use
FDA Drug · Class II · 2021-07-14 · Genentech - Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, I…
FDA Drug · Class III · 2021-05-05 · Genentech - Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only
FDA Drug · Class III · 2018-02-21 · Genentech
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-135-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.