Why it was recalled
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Product description
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Lot numbers, UPCs & expiration codes
Lot 220839, exp 11/30/2013
Where it was sold
Nationwide and Puerto Rico.
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-172-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2012
- FDA report date
- Mar 6, 2013
- Quantity
- 12,948 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amedra Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-172-2013, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 63926
- Address
- 2 Walnut Grove Dr
- Address (line 2)
- Suite 190
- Code information
- Lot 220839, exp 11/30/2013
- Postal code
- 19044-2219
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-172-2013
- Classification
- Class II
- Recalling firm
- Amedra Pharmaceuticals LLC
- Product quantity
- 12,948 bottles
- Termination date
- Mar 21, 2014
- Reason for recall
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Dec 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2013