FDA recall D-578-2013

Product

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Reason for recall

CGMP Deviation; cotton coil is missing in some packaged bottles

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-19

Report date

2013-06-12

Termination date

2013-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-578-2013