Teva Recalls Amphetamine Tablets Due to Unknown Impurity
Teva Pharmaceuticals is recalling specific lots of amphetamine tablets because they failed impurity specifications. The product contains an unknown impurity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to an unknown impurity, which presents a risk of harm where injury has not yet been reported, aligning with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Teva Pharmaceuticals USA is recalling 19,504 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10 mg. The affected product is distributed nationwide and includes bottles with Lot # 34015862A (Exp. Date 6/2016) and Lot # 34016376A (Exp. Date 7/2016). The NDC for the recalled product is 0555-0972-02.
The recall was initiated because the product failed impurities/degradation specifications, specifically due to the presence of an unknown impurity. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.
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 Stimulant
- Affected units
- 19,504
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 (3)
- Lot #: 34015862A
- Exp. Date 6/2016 Lot #: 34016376A
- Exp. Date 7/2016
Distribution
Distributed nationwide across the United States.
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