Recall Enforment Report D-1495-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Akorn, Inc., originally initiated on 08-31-2022 for the product Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31 The product was recalled due to cgmp deviations: turbidity discovered in artificial tears ointment during sterility testing. scope expanded to include other lots and products which potentially share the same root cause.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1495-202208-31-202209-14-2022Class II82,689 tubesLidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.Ongoing
D-1496-202208-31-202209-14-2022Class II48,636 tubesSodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
17478-622Sodium Chloride Sodium ChlorideOintmentOphthalmicAkornHuman Otc Drug
17478-711Lidocaine Lidocaine HydrochlorideJellyTopicalAkornHuman Prescription Drug