Teva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures
Teva Pharmaceuticals is recalling 9,882 bottles of Dextroamphetamine Sulfate 10 mg tablets because stability testing revealed out-of-specification impurities.
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) and cannot be lower.
Plain-English summary
Teva Pharmaceuticals USA is recalling 9,882 bottles of Dextroamphetamine Sulfate Tablets, USP, 10 mg. The affected product is identified by Lot # 34013122A and has an expiration date of 11/15. The NDC number for the recalled product is 0555-0953-02.
The recall was initiated because the product failed impurities/degradation specifications. Specifically, stability testing resulted in an out-of-specification test result for impurities. The agency has classified this as a Class II recall.
The affected bottles were distributed nationwide and in Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SULFATE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Stimulant
- Hazard
- Affected units
- 9,882
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 # 34013122A
- Exp 11/15
Distribution
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