Reported Mar 13, 2013 · Terminated
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate…
Actavis Elizabeth LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Elizabeth LLC · 200 Elmora Ave · Elizabeth, NJ · 07207
Is this the product you have?
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
- Lot codes and dates
- Lot #: 50077231
- Amount recalled
- 9,264 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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