Recalls / Class II
Class IID-1486-2016
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 Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95
- Affected lot / code info
- Lot 152254, exp. 12/31/16, lot 152324, exp. 3/31/17, lot 154833, exp. 5/31/17, lot 162406, exp. 12/31/17
Why it was recalled
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 834 cartons
- Distribution pattern
- Product was distributed in the following states: Nationwide
Timeline
- Recall initiated
- 2016-08-24
- FDA classified
- 2016-09-02
- Posted by FDA
- 2016-09-14
- Terminated
- 2017-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1486-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.