Recall Enforment Report D-0601-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hetero Labs Limited Unit V, originally initiated on 02-13-2018 for the product Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60 The product was recalled due to temperature abuse: valganciclovir tablets usp 450 mg and valacyclovir tablets usp 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of famciclovir complaint batch (d-0415-2018).. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0601-201802-13-201803-21-2018Class II1764 60-count bottlesValganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).Terminated
D-0602-201802-13-201803-21-2018Class II48132 60-count bottlesValacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
31722-704Valacyclovir ValacyclovirTablet, Film CoatedOralCamber Pharmaceuticals, Inc.Human Prescription Drug
31722-705Valacyclovir ValacyclovirTablet, Film CoatedOralCamber Pharmaceuticals, Inc.Human Prescription Drug
31722-832Valganciclovir ValganciclovirTablet, Film CoatedOralCamber Pharmaceuticals, Inc.Human Prescription Drug