Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1061-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 1, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 599 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-1061-2016, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74314
- Address
- 595 N Smith Ave Ste B
- 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
- Postal code
- 92880-6920
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1061-2016
- Classification
- Class III
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 599 bottles
- Termination date
- Oct 14, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 1, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2016