Drug recall D-0601-2018

Class II Terminated reported Mar 21, 2018

Product

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).

Lots and codes

Lot #s VGC17040 & VGC17041, EXP 07/2019

Recall details

Recalling firm
Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
Quantity
1764 60-count bottles
Distribution
NJ and then distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 13, 2018
Terminated
February 18, 2021

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