Class II · Moderate risk Ongoing
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn…
Reason CGMP Deviations:
Eye Drops & Ophthalmic Recalls
Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Class II · Moderate risk Ongoing
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Class II · Moderate risk Terminated
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405…
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which…
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA…
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could…
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL…
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could…
Class III · Low risk Ongoing
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc…
Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India…
Reason Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32…
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could…
Class III · Low risk Ongoing
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g…
Reason Defective Container: Tube split from side seam
Class II · Moderate risk Terminated
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Ongoing
STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC…
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC…
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2…
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL…
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14
Reason cGMP deviations: Temperature abuse
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