Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Amedra Pharmaceuticals LLC is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only. The product is manufactured by Catalent Pharma Solutions for CorePharma, LLC, and carries the NDC 64720-327-09.
The recall is being conducted because the affected lots may not meet the specifications for dissolution over the product shelf life. The specific lot number is 238316, with an expiration date of 01/31/2014.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
- Manufacturer
- Amedra Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,176
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 238316
- exp 01/31/2014
Distribution
Part of a larger recall action
This product is one of 3 recalled by Amedra Pharmaceuticals LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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