Aidarex Recalls Ciprofloxacin Ophthalmic Solution Due to Unknown Impurity
Aidarex Pharmaceuticals is recalling 599 bottles of Ciprofloxacin Ophthalmic Solution because testing revealed out-of-specification results for an unknown impurity.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling 599 bottles of Ciprofloxacin Ophthalmic Solution 0.3% (generic for Ciloxan). The product is a prescription-only ophthalmic solution repackaged by Aidarex and manufactured by Hi-Tech Pharmacal Co., Inc. The recall covers specific lots with expiration dates ranging from May 2016 to February 2017.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, testing identified out-of-specification results for an unknown impurity. The agency has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 599
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Aidarex Pharmaceuticals LLC
See all →- ModerateAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2018-05-23
- ModerateAidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures
FDA (Drugs) · 2017-11-01
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17