Aurobindo Pharma Ltd.

FDA Regulatory Profile

Aurobindo Pharma Ltd. appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0427-2018, Class III) was initiated on February 2, 2018.

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
0
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0427-2018Class IIIMetformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: AurobiFebruary 2, 2018
D-0339-2018Class IAmpicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per cJanuary 2, 2018
D-041-2013Class IINorthstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141March 9, 2012