Recalls / Class I
Class ID-1073-2019
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 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
- Affected lot / code info
- Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019
Why it was recalled
Presence of Particulate Matter; glass particulates
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 283,400 vials
- Distribution pattern
- United States and Puerto Rico
Timeline
- Recall initiated
- 2019-03-15
- FDA classified
- 2019-03-29
- Posted by FDA
- 2019-04-10
- Terminated
- 2021-01-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1073-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.