D-0802-2018 Class II Terminated
FDA drug recall D-0802-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Apr 19, 2018 and is designated Class II. 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… The recall status is terminated (terminated Feb 28, 2019). Affected quantity: 1,908 500-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- Apr 19, 2018
- Termination Date
- Feb 28, 2019
- Product Quantity
- 1,908 500-count bottles
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot 6848501, EXP 04/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0802-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026