Hetero Labs Limited Unit V

FDA Regulatory Profile

Hetero Labs Limited Unit V appears in FDA public data with 9 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1213-2018, Class II) was initiated on August 20, 2018.

Summary

Total Recalls
9 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

hetero labs limited (unit v), hetero labs limited unit v

Recent Recalls

NumberClassProductDate
D-1213-2018Class IIMontelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, UniAugust 20, 2018
D-0081-2019Class IMontelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, August 15, 2018
D-1115-2018Class IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: August 8, 2018
D-1113-2018Class IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: CAugust 8, 2018
D-1114-2018Class IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only ManufacturedAugust 8, 2018
D-1116-2018Class IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for:August 8, 2018
D-0602-2018Class IIValacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, February 13, 2018
D-0601-2018Class IIValganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber PharmaceutiFebruary 13, 2018
D-0415-2018Class IIFamciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. InDecember 22, 2017