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.
Reported: September 21, 2022 Initiated: August 29, 2022 #D-1539-2022
Product 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.
Reason for Recall
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 83,703 bottles
- Distribution
- Nationwide in the US.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 83,703 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 21, 2022. Severity: Moderate. Recall number: D-1539-2022.
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