Recalls / Class II
Class IID-1852-2019
Product
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03
- Brand name
- Bacteriostatic Water
- Generic name
- Bacteriostatic Water
- Active ingredient
- Water
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0409-3977, 0409-1093
- FDA application
- NDA018802
- Affected lot / code info
- Lot #: W20308, Exp. Dec 1, 2019
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 185,700 vials
- Distribution pattern
- Nationwide US and Puerto Rico
Timeline
- Recall initiated
- 2019-09-06
- FDA classified
- 2019-09-12
- Posted by FDA
- 2019-09-18
- Terminated
- 2023-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1852-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.