Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 834 cartons of amphetamine extended-release capsules because blister cavities may contain more than one tablet or capsule.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (potential overdose) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Amerisource Health Services is recalling 834 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg. The affected product is distributed nationwide and includes specific lot numbers with expiration dates ranging from December 2016 to December 2017.
The recall was initiated due to a unit dose mispackaging issue where blister cavities may contain more than one tablet or capsule. This defect poses a risk of accidental overdose or incorrect dosing for patients using the medication.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on proper disposal or replacement. The product is identified by NDC 68084-815-25 for cartons and NDC 68084-815-95 for blisters.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health P
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Affected units
- 834
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 (8)
- Lot 152254
- exp. 12/31/16
- lot 152324
- exp. 3/31/17
- lot 154833
- exp. 5/31/17
- lot 162406
- exp. 12/31/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Amerisource Health Services 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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