D-1061-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 6, 2016
- Initiation Date
- June 1, 2016
- Termination Date
- October 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 599 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Distribution Pattern
Nationwide
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