Drug product
Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
D-0656-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bags
- Official record key
drug-enforcement:D-0656-2023
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 # 37-893787, Exp 04/28/2023; 37-895645, Exp 05/05/2023; 37-897071, Exp 05/11/2023; 37-897802, Exp 05/12/2023; 37-899136, Exp 05/19/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility