Amerisource Recalls Mispackaged Amphetamine Tablets Due to Dosing Errors
Amerisource Health Services is recalling 156 cartons of 30 mg amphetamine tablets because blister cavities may contain more than one tablet.
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 (incorrect dosing) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Amerisource Health Services is recalling 156 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg. The product is identified by Lot 162278, with an expiration date of 10/31/17, and NDC codes 60687-154-25 (carton) and 60687-154-95 (blister).
The recall was initiated because of unit dose mispackaging, where blister cavities may contain more than one tablet. This defect poses a risk of patients receiving an incorrect dose of the medication. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 156
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 162278
- exp. 10/31/17
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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