Amerisource Health Services Recalls Mispackaged Amphetamine Tablets
Amerisource Health Services is recalling 867 cartons of 20 mg amphetamine tablets due to unit dose blister cavities containing 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 (overdose) from a controlled substance where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Amerisource Health Services is recalling 867 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg. The affected product is identified by Lot 162276, with an expiration date of 9/30/17. The product was distributed nationwide.
The recall was initiated because of unit dose mispackaging, where blister cavities may contain more than one tablet. This packaging error poses a risk of accidental overdose if a patient or caregiver assumes a single tablet is present in each cavity.
Healthcare providers and patients should check their inventory for the specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or the recalling firm for disposal or credit.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 867
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 162276
- exp. 9/30/17
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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