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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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