PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 21, 2018 Initiated: December 22, 2017 #D-0415-2018

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.

Details

Units Affected
8,436 bottles
Distribution
Nationwide in the USA.
Location
Jadcherla Mandal, Mahaboob Nagar

Frequently Asked Questions

What product 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. Recalled by Hetero Labs Limited Unit V. Units affected: 8,436 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0415-2018.