Why it was recalled
Presence of Particulate Matter; identified as glass
Product description
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
Lot numbers, UPCs & expiration codes
Lot GX1542, Exp. 01/01/2025
Where it was sold
Nationwide in the USA 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-0233-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 21, 2023
- FDA report date
- Jan 24, 2024
- Quantity
- 34000 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0233-2024, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 93681
- Address
- 235 East 42nd Street
- Code information
- Lot GX1542, Exp. 01/01/2025
- Postal code
- 10017-5703
- Report date
- Jan 24, 2024
- Product type
- Drugs
- Recall number
- D-0233-2024
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 34000 Cartons
- Reason for recall
- Presence of Particulate Matter; identified as glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Dec 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2024