PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 21, 2018 Initiated: February 13, 2018 #D-0602-2018

Product Description

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

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).

Details

Units Affected
48132 60-count bottles
Distribution
NJ and then distributed Nationwide in the USA
Location
Jadcherla Mandal, Mahaboob Nagar

Frequently Asked Questions

What product was recalled?
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. Recalled by Hetero Labs Limited Unit V. Units affected: 48132 60-count bottles.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Drug on March 21, 2018. Severity: Moderate. Recall number: D-0602-2018.