Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for…
Reason Lack of Assurance of Sterility
Is Brimonidine recalled?
10 FDA recalls mention Brimonidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Brimonidine.
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by…
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641…
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL…
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over…
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL…
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over…
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL…
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over…
Class II · Moderate risk Terminated
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA…
Reason cGMP Deviations
Class III · Low risk Terminated
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03…
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed…
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
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