Product Safety Recalls

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TRETINOIN Recall D-1156-2022

Description: Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

TRETINOIN Recall D-1156-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1156-2022
Event ID90430
Original Package?1
Active SubstanceTRETINOIN
Drug RouteORAL
DistributionNationwide in the U.S.
Quantity4941 bottles
Recall ReasonFailed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Drug ClassificationClass II
Drug Code Info20220629
Product NDC0555-0808
Product NUIN0000175607 M0018962
Drug UPC0305550808022
Pharma Class (EPC)Retinoid [EPC]
Pharma Class (CS)Retinoids [CS]
Recall Initiation Date20220614
Report Date20220629
Classification Date20220623
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient Identifier5688UTC01R
Drug Application NumberANDA077684
Structured Product Labeling (SPL ID)4d40143c-dd75-4305-b00e-737e41e5431a
Structured Product Labeling (SPL Set ID)0f81f505-a962-414e-8612-c3ef3b159e9a
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