Drug product
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
D-636-2013
Product summary
- Event
- Event 64661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 ml
- Official record key
drug-enforcement:D-636-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Code information: Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013.
Distribution pattern: FL, GA and SC.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility