Drug recall D-0802-2018
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.
Lots and codes
Lot 6848501, EXP 04/2020
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 1,908 500-count bottles
- Distribution
- Nationwide in the USA
- Recall initiated
- April 19, 2018
- Terminated
- February 28, 2019
Related products
- Sulfamethoxazole and Trimethoprim – drug information
- NDC 53489-145 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 53489-146 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Sun Pharmaceutical Industries, Inc.