Actavis Recalls Ciprofloxacin Ophthalmic Solution Due to Impurity
Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution due to out-of-specification results for an unknown impurity near expiration.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the presence of an unknown impurity, a score of 2 (Moderate) is appropriate as it is a voluntary precautionary recall for a potential quality issue rather than a cosmetic or documentation-only defect.
Plain-English summary
Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution (0.3% as base), sterile, prescription only, in 2.5 mL, 5 mL, and 10 mL bottles. The recall was initiated due to out-of-specification results for an unknown impurity at or near the 24-month expiration date.
The affected product is manufactured by Hi-Tech Pharmacal Co. Inc. and distributed nationwide and in Puerto Rico. The recall covers 447,150 bottles across multiple lot numbers and expiration dates ranging from March 2016 to October 2017.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA classifies this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
- Manufacturer
- Actavis Pharma Inc
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 447,150
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 (20)
- Lot #s: a) 626487
- Exp. 3/31/2016
- 628181
- Exp. 6/30/2016
- 629827
- Exp. 9/30/2016
- 630495
- Exp. 10/31/2016
- 632266
- Exp. 2/28/2017
- 633683 Exp. 4/30/2017
- 347742
- Exp. 09/30/2017
- b) 626487
- 627438
- 628080
- Exp. 5/31/2016
- 628491
- 628634
- Exp. 7/31/2016
Distribution
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