Class II · Moderate risk Terminated
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums…
Reason CGMP Deviations
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or missing package insert.
What was recalled
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.
- Recalling firm
- Sandoz Inc
- NDC code
- 0781-6206-93
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0161-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bimatoprost recalls
See all
Class II · Moderate risk Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in…
Reason CGMP Deviations
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin…
Reason Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class III · Low risk Terminated
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…
Reason Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class III · Low risk Terminated
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Reason Failed Impurities/Degradation Specifications.
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