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DICLOFENAC SODIUM Recall D-0680-2022

Description: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.

DICLOFENAC SODIUM Recall D-0680-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0680-2022
Event ID89798
BrandDICLOFENAC SODIUM 1.5%
Generic NameDICLOFENAC SODIUM TOPICAL SOLUTION
ManufacturerDICLOFENAC SODIUM TOPICAL SOLUTION
Original Package?1
Active SubstanceDICLOFENAC SODIUM
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity36,018 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 NDC70512-025
Drug UPC0370512025052
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient IdentifierQTG126297Q
Drug Application NumberANDA202769
Structured Product Labeling (SPL ID)b8bd41e9-b7a5-5daa-e053-2a95a90ad691
Structured Product Labeling (SPL Set ID)5e1f20e0-4743-fc3c-e053-2991aa0aa7ad
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