Drug product
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
D-0711-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 mL total
- Official record key
drug-enforcement:D-0711-2017
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 # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility