Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Specifications
Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.
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 as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution, 0.03%, 7.5 mL bottles. The product is manufactured by Lupin Limited in Pithampur, India, and was distributed nationwide in the U.S. The specific lot affected is H801686, with an expiration date of 12/31/2019.
The recall was initiated because an out-of-specification result was observed in an individual impurity, failing the impurities/degradation specifications. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 2,130
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# H801686
- Exp. 12/31/2019.
Distribution
Distributed nationwide across the United States.
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