PlainRecordsFDA · Drug recall
Dextroamphetamine Sulfate Extended Release Capsules… and 2 more products
- Date
- March 6, 2013
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Amedra Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Distribution pattern
- Nationwide and Puerto Rico.
3 products in this recall
Dextroamphetamine Sulfate Extended Release Capsules…
- Product
- Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
- Quantity
- 1,176 bottles
- Codes and lots
- Lot 238316, exp 01/31/2014
- Recall started
- Dec. 4, 2012
- Recall number
- D-171-2013
Dextroamphetamine Sulfate Extended Release Capsules…
- Product
- 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
- Quantity
- 12,948 bottles
- Codes and lots
- Lot 220839, exp 11/30/2013
- Recall started
- Dec. 4, 2012
- Recall number
- D-172-2013
Dextroamphetamine Sulfate Extended Release Capsules…
- Product
- Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
- Quantity
- 10,968 bottles
- Codes and lots
- Lot 220843, exp 11/30/2013
- Recall started
- Dec. 4, 2012
- Recall number
- D-173-2013
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-171-2013, D-172-2013, D-173-2013. The agency record governs; check it and the company before acting.