FDA recall D-0078-2022

Product

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

Reason for recall

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-10-18

Report date

2021-11-03

Termination date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0078-2022