Recalls / Class III
Class IIID-1061-2016
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
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave Ste B, Corona, California 92880-6920
Distribution
- Quantity
- 599 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-01
- FDA classified
- 2016-06-30
- Posted by FDA
- 2016-07-06
- Terminated
- 2016-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1061-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.