Why it was recalled
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Product description
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Lot numbers, UPCs & expiration codes
Lot: 33045BA, EXP 1SEP2023
Where it was sold
USA nationwide 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-0184-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 22, 2022
- FDA report date
- Feb 1, 2023
- Quantity
- 89,700 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0184-2023, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 91346
- Address
- 235 East 42nd Street
- Code information
- Lot: 33045BA, EXP 1SEP2023
- Postal code
- 10017-5703
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0184-2023
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 89,700 vials
- Termination date
- Aug 7, 2024
- Reason for recall
- Presence of Particulate Matter: Glass particulate matter detected in injectable.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
- Distribution pattern
- USA nationwide and Puerto Rico
- Recall initiation date
- Dec 22, 2022
- Initial firm notification
- Press Release
- Center classification date
- Jan 25, 2023