Product Safety Recalls

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Recall D-0679-2022

Description: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

Recall D-0679-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0679-2022
Event ID89798
BrandDICLOVIX M
Generic NameDICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH
ManufacturerDICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH
Original Package?1
DistributionNationwide in the USA and Puerto Rico
Quantity16,643 bottles
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC72275-719
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Drug Application NumberANDA202769
Structured Product Labeling (SPL ID)9d001257-2092-2a0c-e053-2a95a90ad767
Structured Product Labeling (SPL Set ID)9d0012ed-a50a-a936-e053-2995a90a6100
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