Recalls / Class I
Class ID-0865-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot # 56-148-EV, Exp 8/1/2017
Why it was recalled
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 72,000 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-18
- FDA classified
- 2016-05-23
- Posted by FDA
- 2016-06-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0865-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.