Drug product
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
D-0732-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5207 bags
- Official record key
drug-enforcement:D-0732-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Code information: Lot # 37-888736, 37-888769, Exp 05/02/2023; 37-890465, 37-890483, Exp 05/09/2023; 37-892088, 37-892117, 37-892119, 37-892145, Exp 05/16/2023; 37-893759, 37-893765, Exp 05/23/2023; 37-895742, 37-895751, Exp 05/30/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility