Drug product
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
D-1073-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82362
- Status
- Terminated
- Classification
- Class I
- Quantity
- 283,400 vials
- Official record key
drug-enforcement:D-1073-2019
Official wording
Reason: Presence of Particulate Matter; glass particulates
Code information: Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019
Distribution pattern: United States and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter