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Recall Observatory FDA recall evidence

Drug 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

D-0601-2018

February 13, 2018

Class II

Product summary

Firm
Hetero Labs Limited Unit V
Event
Event 79142
Status
Terminated
Classification
Class II
Quantity
1764 60-count bottles
Official record key
drug-enforcement:D-0601-2018

Official wording

Reason: 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).

Code information: Lot #s VGC17040 & VGC17041, EXP 07/2019

Distribution pattern: NJ and then distributed Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).