Drug product
DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
D-0714-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 214 vials
- Official record key
drug-enforcement:D-0714-2017
Official wording
Reason: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Code information: Lot # t12-16-2016@73, Exp 4/18/2017; t12-27-2016@93, Exp 4/27/2017; t01-09-2017@102, Exp 5/10/2017; t01-10-2017@120, Exp 5/11/2017; 02-01-2017@78, Exp 6/1/2017; t02-08-2017@96, Exp 6/9/2017; t02-20-2017@80, Exp 6/21/2017; t02-21-2017@122, Exp 6/23/2017; t02-23-2017@68, Exp 6/24/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility