Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Actavis Elizabeth LLC is recalling 42 bottles of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, because they failed dissolution specifications.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving a potential therapeutic failure without immediate physical harm.
Plain-English summary
Actavis Elizabeth LLC is recalling 42 bottles of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles. The product is identified by NDC 45963-305-09, Lot # 2020E141, and expiration date 07/15.
The recall was initiated because the product failed dissolution specifications. Dissolution tests ensure that the medication releases the active ingredient at the correct rate; failure to meet these specifications may result in the medication not working as intended.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SULFATE
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 42
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 #: 2020E141
- Exp 07/15
UPCs (4)
- 0345963305091
- 0345963304094
- 0345963303097
- 345963305091
Distribution
Distributed nationwide across the United States.
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