Could cause temporary or reversible harm; serious harm is unlikely.
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-[redacted-phone]).
| Brand name | VALGANCICLOVIR |
| Generic name | VALGANCICLOVIR |
| Active ingredient(s) | VALGANCICLOVIR HYDROCHLORIDE |
| Distributed by / 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 |
| Full product label | 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 |
| Recalling firm | Hetero Labs Limited Unit V |
| Distribution | NJ and then distributed Nationwide in the USA |
| Quantity | 1764 60-count bottles |
| Recall initiated | 2018-02-13 |
| Report date | 2018-03-21 |
| Recall completed | 2021-02-18 |
| Recall number | D-0601-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Jadcherla Mandal, Mahaboob Nagar India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗