Amedra Pharmaceuticals LLC

FDA Regulatory Profile

Amedra Pharmaceuticals LLC appears in FDA public data with 4 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-385-2014, Class II) was initiated on October 7, 2013.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-385-2014Class IIDexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, October 7, 2013
D-171-2013Class IIDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by CatDecember 4, 2012
D-173-2013Class IIDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by CatDecember 4, 2012
D-172-2013Class IIDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by CatDecember 4, 2012