FDA recall D-0544-2018

Product

Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Reason for recall

Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-02-09

Report date

2018-03-07

Termination date

2019-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fountain Run, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2018