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
Is Bimatoprost recalled?
8 FDA recalls mention Bimatoprost. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bimatoprost.
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%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC…
Reason Labeling: Incorrect or missing package insert.
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.
Class III · Low risk Terminated
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Bimatoprost active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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