Status
Completed
Drug Enforcement D-0097-2023
Lack of assurance of sterility: Bags have the potential to leak.
Classification
Class II
Report Date
January 11, 2023
Termination Date
—
Product Information
- Product description
- 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,
- Product quantity
- 62,088 bags
- Reason for recall
- Lack of assurance of sterility: Bags have the potential to leak.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0097-2023
- Event ID
- 91379
- Recall initiation date
- December 29, 2022
- Center classification date
- January 5, 2023
- Code info
- Lot: 5935283, Exp. 12/01/2023
- More code info
- —