International Laboratories, LLC

FDA Regulatory Profile

International Laboratories, LLC appears in FDA public data with 4 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0234-2018, Class II) was initiated on January 12, 2018.

Summary

Total Recalls
4 (2 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0234-2018Class IIPravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individualJanuary 12, 2018
D-0233-2018Class IIPravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individualJanuary 12, 2018
D-0472-2018Class IClopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International LaboratorieJanuary 4, 2018
D-0102-2018Class IPravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International LaboraAugust 7, 2017