Teva Recalls Mixed Strength Amphetamine Salts Tablets
Teva Pharmaceuticals USA is recalling specific bottles of mixed amphetamine salts tablets because some may contain mixed strengths.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential dosing error due to mixed strengths, which fits the criteria for a moderate severity recall involving labeling or product integrity issues without reported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling 33,280 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg, 100 count bottles. The recall is being conducted because some bottles may contain mixed strengths of the product.
The affected product is identified by Lot # 42614718 with an expiration date of 02/2021. The product was distributed nationwide within the United States and Puerto Rico. This is a prescription-only medication.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, patients should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 33,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 42614718
- Exp. date 02/2021
Distribution
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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