Allergan Recalls Blephamide Ophthalmic Ointment Due to Impurity Failures
Allergan is recalling 648 units of Blephamide ophthalmic ointment because stability testing showed impurities exceeding specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for potential temporary or medically reversible adverse health consequences.
Plain-English summary
Allergan Sales, LLC is recalling 648 units of Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tubes. The product is prescription-only and was distributed nationwide in the US. The specific lot affected is 93802, with an expiration date of November 2019.
The recall was initiated because stability testing results did not meet the specification for impurities. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The product is manufactured by Allergan in Irvine, California.
The recalled product
- Product
- Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 648
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 (2)
- Lot: 93802
- EXP NOV 2019
Distribution
Distributed nationwide across the United States.
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