Genentech Recalls Trastuzumab Kits Due to Potential Glass Particulates
Genentech is recalling 2,140 Trastuzumab Kits for investigational use because the included Bacteriostatic Water for Injection diluent vials may contain glass particulates.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of glass particulates in an injectable diluent presents a significant risk of injury.
Plain-English summary
Genentech, Inc. is recalling 2,140 Trastuzumab Kits intended for investigational use. The recall is due to the potential presence of glass particulates in the Bacteriostatic Water for Injection, USP diluent vials packed with the kits.
The affected product is Lot # 454138, with an expiration date of 07/14. This lot includes Trastuzumab Lot # 886618 (Exp 12/14) and Bacteriostatic Water for Injection, USP Lot # 08-368-DK-01 (Exp 07/14). The kits were distributed nationwide.
Because these kits are designated for investigational use only, they are not intended for general consumer use. Healthcare facilities and research institutions should stop using the affected lots and contact Genentech for further instructions.
The recalled product
- 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…
- Manufacturer
- Genentech Inc
- Affected units
- 2,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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)
Distribution
Distributed nationwide across the United States.
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