Recall Enforment Report D-0259-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teligent Pharma, Inc., originally initiated on 10-19-2021 for the product Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05. The product was recalled due to defective container. 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-0259-202210-19-202112-01-2021Class II5400 unitsDiclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.Defective ContainerOngoing
D-0258-202210-19-202112-01-2021Class II2664 bottlesDiclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05Defective ContainerOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
70512-025Diclofenac Sodium 1.5% Diclofenac Sodium Topical SolutionSolutionTopicalSola PharmaceuticalsHuman Prescription Drug
72275-719Diclovix M Diclofenac Sodium, With Camphor, Lidocaine, And Methyl Salicylate PatchKitPrimary Pharmaceuticals, IncHuman Prescription Drug