Recalls / Class II
Class IID-0097-2023
Product
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
- Brand name
- Heparin Sodium
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0409-1005, 0409-7620, 0409-2222
- FDA application
- NDA018916
- Affected lot / code info
- Lot: 5935283, Exp. 12/01/2023
Why it was recalled
Lack of assurance of sterility: Bags have the potential to leak.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 62,088 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-12-29
- FDA classified
- 2023-01-05
- Posted by FDA
- 2023-01-11
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.