Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities
Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of the specific nature of the impurity failure.
Plain-English summary
Teva Pharmaceuticals USA is recalling 19,545 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10 mg. The affected product is a prescription-only medication (CII) packaged in 100-tablet bottles with NDC 0555-0972-02. The recall includes lot numbers 34016373A and 34016377A, both with an expiration date of 7/2016.
The recall was initiated because the product failed impurities and degradation specifications, specifically testing out of specification for unknown impurities. The agency classification for this recall is Class II.
The affected product was distributed nationwide, including Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for disposal or replacement.
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
- Hazard
- Affected units
- 19,545
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 (4)
- Lot #: 34016373A
- Expiry: 7/2016
- Lot #: 34016377A
- Expiry: 7/2016.
Distribution
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