FDA recall D-0415-2018

Product

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

Reason for recall

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.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-12-22

Report date

2018-02-21

Termination date

2020-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jadcherla Mandal, Mahaboob Nagar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2018