Romark Laboratories, L.C.

FDA Regulatory Profile

Romark Laboratories, L.C. appears in FDA public data with 1 recall, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0983-2015, Class II) was initiated on April 24, 2015.

Summary

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

Recent Recalls

NumberClassProductDate
D-0983-2015Class IIAlinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured foApril 24, 2015