Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: W20308, Exp. Dec 1, 2019
Where it was sold
Nationwide US and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1852-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 185,700 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1852-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83699
- Address
- 235 E 42nd St
- Code information
- Lot #: W20308, Exp. Dec 1, 2019
- Postal code
- 10017-5703
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1852-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 185,700 vials
- Termination date
- Mar 25, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide US and Puerto Rico
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 12, 2019