Drug recall D-0415-2018

Class II Terminated reported Feb 21, 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.

Lots and codes

Lot # FMC17039, Exp 07/2019.

Recall details

Recalling firm
Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
Quantity
8,436 bottles
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
December 22, 2017
Terminated
February 5, 2020

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