Drug product
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
D-0865-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 73653
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 72,000 units
- Official record key
drug-enforcement:D-0865-2016
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Code information: Lot # 56-148-EV, Exp 8/1/2017
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter