FDA recall D-1295-2014

Product

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Reason for recall

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-03-24

Report date

2014-05-21

Termination date

2014-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1295-2014