Drug product
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
D-0755-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1673 bags
- Official record key
drug-enforcement:D-0755-2023
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 # 37-885553, 37-885554, Exp 05/09/2023; 37-887923, 37-887924, Exp 05/18/2023; 37-890778, 37-890779, Exp 05/30/2023; 37-892847, Exp 06/07/2023; 37-895049, Exp 06/15/2023; 37-898480, 37-898481, Exp 06/29/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility