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AMPHETAMINE ASPARTATE MONOHYDRATE Recall D-1539-2022

Description: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.

AMPHETAMINE ASPARTATE MONOHYDRATE Recall D-1539-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1539-2022
Event ID90803
BrandDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Generic NameDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
ManufacturerDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Original Package?1
Active SubstanceAMPHETAMINE ASPARTATE MONOHYDRATE AMPHETAMINE SULFATE
Drug RouteORAL
DistributionNationwide in the US.
Quantity83,703 bottles
Recall ReasonLabeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Drug ClassificationClass II
Drug Code Info20220921
Product NDC0555-0775 0555-0971 0555-0972
Recall Initiation Date20220829
Report Date20220921
Classification Date20220916
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient Identifier6DPV8NK46S G83415V073
Drug Application NumberANDA040422
Structured Product Labeling (SPL ID)60b73622-b1ec-4d4d-b2b8-e109a8f17f7e
Structured Product Labeling (SPL Set ID)cffbbb15-d776-41ae-a8a6-687f2c07bfa4
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