Home / Recalls / Hetero Labs Limited Unit V / D-1116-2018

D-1116-2018 Class II

Recalled by Hetero Labs Limited Unit V — Jadcherla Mandal, Mahaboob Nagar

Recall Details

Product Type
Drugs
Report Date
August 29, 2018
Initiation Date
August 8, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
441,408 bottles

Product Description

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Nationwide

Code Information

All Lots with expiration dates 7/2018 to 6/2020

Other recalls by Hetero Labs Limited Unit V

  • D-1213-2018 Class II — Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hete (August 20, 2018)
  • D-0081-2019 Class I — Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero La (August 15, 2018)
  • D-1113-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only (August 8, 2018)
  • D-1114-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx (August 8, 2018)
  • D-1115-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only (August 8, 2018)
  • D-0601-2018 Class II — Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured fo (February 13, 2018)
  • D-0602-2018 Class II — Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camb (February 13, 2018)
  • D-0415-2018 Class II — Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber (December 22, 2017)