Drug product
DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
D-0715-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 mL total
- Official record key
drug-enforcement:D-0715-2017
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 # 02-23-2017@36, Exp 5/24/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility