Recalls / Class III
Class IIID-0161-2020
Product
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
- Brand name
- Bimatoprost
- Generic name
- Bimatoprost
- Active ingredient
- Bimatoprost
- Route
- Ophthalmic
- NDC
- 0781-6206
- FDA application
- ANDA202719
- Affected lot / code info
- 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, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021.
Why it was recalled
Labeling: Incorrect or missing package insert.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 346,929 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-10-17
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0161-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.