Why it was recalled
Presence of Particulate Matter; identified as glass
Product description
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).
Lot numbers, UPCs & expiration codes
Lot GY2496, Exp 02/01/2025
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-0235-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 21, 2023
- FDA report date
- Jan 24, 2024
- Quantity
- 24400 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0235-2024, 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 GY2496, Exp 02/01/2025
- Postal code
- 10017-5703
- Report date
- Jan 24, 2024
- Product type
- Drugs
- Recall number
- D-0235-2024
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 24400 Cartons
- Reason for recall
- Presence of Particulate Matter; identified as glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (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