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
Reported: July 6, 2016 Initiated: June 1, 2016 #D-1061-2016
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.
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 599 bottles
- Distribution
- Nationwide
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 599 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2016. Severity: Low. Recall number: D-1061-2016.
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