Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.
Plain-English summary
Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90-count bottles. The recall was initiated because the product failed to meet dissolution specifications. The affected product is identified by Lot # 3803J141 with an expiration date of 7/2016.
The recall involves 8,062 units of the medication, which was distributed nationwide. The product is a prescription-only medication manufactured by Actavis Elizabeth LLC and distributed by Actavis Pharma, Inc.
Consumers who have this specific lot of Dextroamphetamine Sulfate Extended-Release Capsules should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SULFATE
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,062
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 #: 3803J141
- Exp. 7/2016
UPCs (3)
- 0345963305091
- 0345963304094
- 0345963303097
Distribution
Distributed nationwide across the United States.
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