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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1539-2022 |
| Event ID | 90803 |
| Brand | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE |
| Generic Name | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE |
| Manufacturer | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE |
| Original Package? | 1 |
| Active Substance | AMPHETAMINE ASPARTATE MONOHYDRATE AMPHETAMINE SULFATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the US. |
| Quantity | 83,703 bottles |
| Recall Reason | Labeling: 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 Classification | Class II |
| Drug Code Info | 20220921 |
| Product NDC | 0555-0775 0555-0971 0555-0972 |
| Recall Initiation Date | 20220829 |
| Report Date | 20220921 |
| Classification Date | 20220916 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6DPV8NK46S G83415V073 |
| Drug Application Number | ANDA040422 |
| 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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