FDA recall D-0659-2020

Product

Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ

Reason for recall

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Distribution

Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.

Key facts

Status

Terminated

Initiation date

2019-12-26

Report date

2020-01-22

Termination date

2020-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0659-2020