FDA recall D-1278-2019

Product

Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.

Reason for recall

Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-29

Report date

2019-05-22

Termination date

2021-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1278-2019