Drug product
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
D-1061-2016
Product summary
- Event
- Event 74314
- Status
- Terminated
- Classification
- Class III
- Quantity
- 599 bottles
- Official record key
drug-enforcement:D-1061-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Code information: Lot # : a) 44704-1, 44899-1, 45153-1, 45387-1 Exp. 10/2016, 45449-1, 45801-1, 47647-1, Exp. 02/2017 b) 40990-1 Exp: 05/2016, 45960-1 Exp. 08/2016, 45316-1, 45961-1 Exp. 09/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification