Home / Recalls / Hetero Labs Limited Unit V / D-0601-2018

D-0601-2018 Class II Terminated

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

Recall Details

Product Type: Drugs
Report Date: March 21, 2018
Initiation Date: February 13, 2018
Termination Date: February 18, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1764 60-count bottles

Product Description

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60

Reason for Recall

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Distribution Pattern

NJ and then distributed Nationwide in the USA

Code Information

Lot #s VGC17040 & VGC17041, EXP 07/2019

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-1114-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx (August 8, 2018)
D-1116-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only (August 8, 2018)
D-1113-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only (August 8, 2018)
D-1115-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only (August 8, 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)