Recalls / Class II
Class IID-1482-2016
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95
- Affected lot / code info
- Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17
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
- 2,276 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-1482-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.