FDA recall D-0572-2016

Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

Reason for recall

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

Distribution

MS

Key facts

Status

Terminated

Initiation date

2015-10-09

Report date

2016-01-27

Termination date

2016-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2016