Home / Recalls / Hetero Labs Limited Unit V / D-0415-2018

D-0415-2018 Class II Terminated

Recalled by Hetero Labs Limited Unit V — Jadcherla Mandal, Mahaboob Nagar

Recall Details

Product Type
Drugs
Report Date
February 21, 2018
Initiation Date
December 22, 2017
Termination Date
February 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,436 bottles

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.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot # FMC17039, Exp 07/2019.

Other recalls by Hetero Labs Limited Unit V

  • D-1213-2018 Class II — Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hete (August 20, 2018)
  • D-0081-2019 Class I — Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero La (August 15, 2018)
  • D-1114-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx (August 8, 2018)
  • D-1116-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only (August 8, 2018)
  • D-1113-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only (August 8, 2018)
  • D-1115-2018 Class II — Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only (August 8, 2018)
  • D-0602-2018 Class II — Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camb (February 13, 2018)
  • D-0601-2018 Class II — Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured fo (February 13, 2018)