Allergan Recalls FML Ophthalmic Ointment Due to Particulate Matter
Allergan is recalling specific lots of FML ophthalmic ointment because small black particles from the tube cap may be present in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 FDA classified this as a Class II recall. The hazard involves particulate matter from the packaging cap, which is a quality issue rather than a high-risk biological pathogen or structural defect causing severe injury.
Plain-English summary
Allergan Sales, LLC is recalling 28,292 tubes of FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g. The recall affects specific lots with expiration dates in September 2016, December 2016, and February 2017. The product was distributed nationwide, as well as in Puerto Rico and Barbados.
The recall was initiated due to customer complaints regarding the presence of small black particles. These particles were identified as fragments of the ointment tube cap, generated when the cap is unscrewed from the aluminum tube. This action potentially introduces the particles into the ophthalmic ointment.
Consumers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 28,292
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 #: 86258
- Exp 09/16
- 87189
- Exp 12/16
- 87514
- Exp 02/17
Distribution
Part of a larger recall action
This product is one of 4 recalled by Allergan Sales, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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