FDA-Drug2018-03-21Class II

Valacyclovir Tablets USP 1 gram, 30-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 # 31722-705-30

Hetero Labs Limited Unit V
Hazard

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).

Sold states
NJ and then distributed Nationwide in the USA
Affected count
48132 60-count bottles
Manufactured in
Unit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill., Jadcherla Mandal, Mahaboob Nagar, India
Products
Valacyclovir Tablets USP 1 gram, 30-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 # 31722-705-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0602-2018

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