FDA-Drug2020-01-22Class II

Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

Sun Pharmaceutical Industries, Inc.
Hazard

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

Sold states
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Affected count
207,585 blisters
Manufactured in
270 Prospect Plains Rd, Cranbury, NJ, United States
Products
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2020

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief