Why it was recalled
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Product description
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
Lot numbers, UPCs & expiration codes
Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17
Where it was sold
Product was distributed in the following states: Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1482-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 2,276 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-1482-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75076
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17
- Postal code
- 43217-1188
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1482-2016
- Classification
- Class II
- Recalling firm
- Amerisource Health Services
- Product quantity
- 2,276 cartons
- Termination date
- Dec 18, 2017
- Reason for recall
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed in the following states: Nationwide
- Recall initiation date
- Aug 24, 2016
- Initial firm notification
- Center classification date
- Sep 2, 2016