Actavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure
Actavis Inc is recalling specific lots of Levofloxacin Ophthalmic Solution because the product failed impurity specifications for a related compound.
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 indicates the product is not likely to cause adverse health consequences. The hazard involves a chemical impurity failure without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Actavis Inc is recalling Levofloxacin Ophthalmic Solution, 0.5%, sterile, packaged in 5mL bottles. The product is prescription-only and was manufactured by Hi-Tech Pharmacal Co., Inc. The recall covers 14,280 bottles distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, the product tested out of specification for a related compound, levofloxacin n-oxide, at the 18-month stability time point. The affected lots are #348748 (Exp 11/30/2017), #350578 (Exp 3/31/2018), and #633467 (Exp 3/31/2017).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
- Manufacturer
- Actavis Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 14,280
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 (6)
- Lot # 348748
- Exp 11/30/2017
- 350578
- Exp 3/31/2018
- 633467
- Exp 3/31/2017
Distribution
Distributed nationwide across the United States.
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