Valganciclovir Tablets recalled over temperature-control failures

Recall date

February 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hetero Labs Limited Unit V recalls Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway…

Recall number

D-0601-2018

FDA classification

Class II

Brand / firm

Hetero Labs Limited Unit V

Sold / distributed

NJ and then distributed Nationwide in the USA

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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