FDA (Drugs) recall action 79142
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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 agency’s own wording, quoted from the enforcement report.
Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.
Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.