Drug product
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).
D-0235-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 93681
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 24400 Cartons
- Official record key
drug-enforcement:D-0235-2024
Official wording
Reason: Presence of Particulate Matter; identified as glass
Code information: Lot GY2496, Exp 02/01/2025
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter