Drug product
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
D-0786-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5/2 mL vials
- Official record key
drug-enforcement:D-0786-2017
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 # t01-31-2017@119, Exp 5/2/2017; t02-01-2017@130, Exp 5/4/2017
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility