Drug product
Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
D-0648-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 307 bags
- Official record key
drug-enforcement:D-0648-2023
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 # 37-894942, Exp 05/01/2023; 37-896485, Exp 05/07/2023; 37-896793, Exp 05/08/2023; 37-898247, Exp 05/14/2023; 37-899149, Exp 05/19/2023; 37-900610, Exp 05/25/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility