Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals....
FDA Recall #D-0415-2018 — Class II — December 22, 2017
Product Description
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.
Recalling Firm
Hetero Labs Limited Unit V — Jadcherla Mandal, Mahaboob Nagar
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,436 bottles
Distribution
Nationwide in the USA.
Code Information
Lot # FMC17039, Exp 07/2019.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated