Famciclovir Tablets recalled over temperature-control failures

Recall date

December 22, 2017

Source

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

Official notice title

Hetero Labs Limited Unit V recalls Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 0…

Recall number

D-0415-2018

FDA classification

Class II

Brand / firm

Hetero Labs Limited Unit V

Sold / distributed

Nationwide in the USA.

Why it was recalled

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

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

What was recalled

Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30