Drug product
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
D-1177-2017
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 78048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,725 vials
- Official record key
drug-enforcement:D-1177-2017
Official wording
Reason: Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Code information: Lot: 63-075-DK Exp. FEB 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.