Reported Jul 6, 2016 · Terminated
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG:…
Aidarex Pharmaceuticals LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aidarex Pharmaceuticals LLC · 595 N Smith Ave Ste B · Corona, CA · 92880-6920
Is this the product you have?
- Ciprofloxacin OPTH 0.3% SOL
- generic forCiloxan, Rx Only, 2.5 mL Bottle
- Repackaged byAidarex Pharmaceuticals
- MFGHi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
- Lot codes and dates
Lot # : a) 44704-144899-145153-145387-1 Exp. 10/201645449-145801-147647-1Exp. 02/2017
- b) 40990-1 Exp
05/201645960-1 Exp. 08/201645316-145961-1 Exp. 09/2016
- Amount recalled
- 599 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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