FDA recall D-0601-2018

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).

Distribution

NJ and then distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-02-13

Report date

2018-03-21

Termination date

2021-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jadcherla Mandal, Mahaboob Nagar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0601-2018