FDA recall D-0843-2020

Product

Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-02-10

Report date

2020-02-19

Termination date

2020-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0843-2020