Sandoz Recalls Bimatoprost Ophthalmic Solution Due to Missing Package Insert
Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03% because the package insert is incorrect or missing. The recall covers 346,929 bottles distributed nationwide.
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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a packaging/labeling issue (missing insert) without reported injuries.
Plain-English summary
Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03%, a prescription medication for topical application to the upper eyelid. The recall is due to a labeling defect where the package insert is incorrect or missing. The affected product is manufactured by Alcon Laboratories, Inc. for Sandoz Inc. and is available in 3 mL and 5 mL bottles.
A total of 346,929 bottles are included in this recall. The affected lots have expiration dates ranging from November 30, 2019, to May 31, 2021. The product was distributed nationwide in the United States.
Consumers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- BIMATOPROST (BIMATOPROST)
- Brand
- BIMATOPROST
- Manufacturer
- Sandoz Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 346,929
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 (20)
- Lot #s: a) 290635FA
- 290635FB
- Exp. 11/30/2019
- 293230F
- Exp. 6/30/2020
- 294628F
- 301337F
- Exp. 11/30/2020
- 304451FA
- Exp. 1/31/2021. b) 290636FA
- 290636FB
- 290636FC
- 293233FA
- 293233FB
- Exp. 5/31/2020
- 293234FA
- 293234FB
- 294630F
- 301338FA
- 301338FB
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sandoz Inc 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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