Why it was recalled
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Product description
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Lot numbers, UPCs & expiration codes
Lot# 243459; Exp. 01/14
Where it was sold
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-385-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2013
- FDA report date
- Jan 1, 2014
- Quantity
- 10,992 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amedra Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-385-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66593
- Address
- 2 Walnut Grove Dr
- Address (line 2)
- Suite 190
- Code information
- Lot# 243459; Exp. 01/14
- Postal code
- 19044-2219
- Report date
- Jan 1, 2014
- Product type
- Drugs
- Recall number
- D-385-2014
- Classification
- Class II
- Recalling firm
- Amedra Pharmaceuticals LLC
- Product quantity
- 10,992 bottles
- Termination date
- Oct 7, 2014
- Reason for recall
- Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2013