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DICLOFENAC SODIUM Recall D-0714-2022

Description: Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05

DICLOFENAC SODIUM Recall D-0714-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0714-2022
Event ID89807
BrandDICLOFENAC SODIUM
Generic NameDICLOFENAC SODIUM
ManufacturerDICLOFENAC SODIUM
Active SubstanceDICLOFENAC SODIUM
Drug RouteTOPICAL
DistributionNationwide within the United States
Quantity312 bottles
Recall ReasonDefective Container: Leaking containers.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC61919-675 61919-874
Recall Initiation Date20211207
Report Date20220330
Classification Date20220322
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient IdentifierQTG126297Q
Drug Application NumberANDA202769
Structured Product Labeling (SPL ID)94e0cb71-8733-d8a5-e053-2995a90a6792
Structured Product Labeling (SPL Set ID)3d976518-60d2-478a-e054-00144ff88e88
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