D-0602-2018 Class II Terminated
FDA drug recall D-0602-2018 was initiated by Hetero Labs Limited Unit V on February 13, 2018 and is designated Class II. Reason for recall: 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 ba… The recall status is terminated (terminated February 18, 2021). Affected quantity: 48132 60-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 21, 2018
- Initiation Date
- February 13, 2018
- Termination Date
- February 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48132 60-count bottles
Product Description
Valacyclovir 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 # 31722-705-30
Reason for Recall
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).
Distribution Pattern
NJ and then distributed Nationwide in the USA
Code Information
Lot # VLC17027 Exp 07-2019