Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures
Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity rubric for documentation or minor specification issues without reported harm.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Bimatoprost Ophthalmic Solution 0.03%, a prescription-only ophthalmic product. The recall involves 9,930 bottles in 5 mL and 7.5 mL packages, manufactured by Lupin Limited in India and distributed nationwide within the United States.
The recall was initiated due to failed impurities and degradation specifications. Out-of-specification (OOS) results were observed in any other individual impurity and total impurities. The FDA has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Patients who have this product should stop using it and consult their healthcare provider. Specific lot numbers and expiration dates are listed in the official recall notice, including codes H804506, 803555, H805394, H804112, and H803220 with expiration dates ranging from March 2020 to August 2020.
The recalled product
- Product
- Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 9,930
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 (5)
- a) H804506 Exp. 06/2020
- 803555 Exp. 04/2020
- H805394
- Exp. 08/2020 b) H804112 Exp. 05/2020
- H803220 Exp. 03/2020
Distribution
Distributed nationwide across the United States.
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