Drug product
heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
D-0726-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3055 bags
- Official record key
drug-enforcement:D-0726-2023
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 # 37-888668, 37-888685, 37-888701, Exp 05/02/2023; 37-890550, 37-890556, Exp 05/09/2023; 37-892201, 37-892216, Exp 05/16/2023; 37-893866, 37-893917, 37-893918, Exp 05/23/2023; 37-895705, 37-895717, Exp 05/30/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility