FDA recall D-150-2013

Product

Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Reason for recall

Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-07

Report date

2013-02-13

Termination date

2014-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-150-2013