FDA recall D-0802-2018

Sun Pharmaceutical Industries, Inc. · Class II · drug

Product

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

Reason for recall

Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-04-19
Report date: 2018-05-23
Termination date: 2019-02-28
Voluntary/Mandated: —
Location: Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2018