Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0415-2018

December 22, 2017

Class II

Product summary

Firm
Hetero Labs Limited Unit V
Event
Event 78811
Status
Terminated
Classification
Class II
Quantity
8,436 bottles
Official record key
drug-enforcement:D-0415-2018

Official wording

Reason: 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.

Code information: Lot # FMC17039, Exp 07/2019.

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.