D-1177-2017 Class II Terminated
FDA drug recall D-1177-2017 was initiated by Pfizer Inc. on September 1, 2017 and is designated Class II. Reason for recall: Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. The recall status is terminated (terminated January 24, 2020). Affected quantity: 18,725 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 4, 2017
- Initiation Date
- September 1, 2017
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,725 vials
Product Description
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
Reason for Recall
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 63-075-DK Exp. FEB 2019