Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Sa
Summary
The FDA issued a Class II for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate a by Teva Pharmaceuticals USA Inc. 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 .
Details
Source
Drug Recall
External ID
D-1539-2022
Action Date
2022-09-21
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #: 100023340, Exp 10/2024
Quantity Affected: 83,703 bottles
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.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-29
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 76 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1539-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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