OPMX, LLC

FDA Regulatory Profile

OPMX, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (D-300-2013, Class II) was initiated on April 12, 2013.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-300-2013Class IIPentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, DistrApril 12, 2013
D-299-2013Class IIPentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tabApril 12, 2013