Recalls / Class II
Class IID-1177-2017
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
- Affected lot / code info
- Lot: 63-075-DK Exp. FEB 2019
Why it was recalled
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 18,725 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-01
- FDA classified
- 2017-09-22
- Posted by FDA
- 2017-10-04
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1177-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.