Drug product
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
D-650-2013
Product summary
- Event
- Event 64661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70ml total
- Official record key
drug-enforcement:D-650-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: Lot number CABDAFAD:09, Exp date: 5/4/2013
Distribution pattern: FL, GA and SC.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility