Recalls / Class II
Class IID-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
- Brand name
- Sulfamethoxazole And Trimethoprim
- Generic name
- Sulfamethoxazole And Trimethoprim
- Active ingredients
- Sulfamethoxazole, Trimethoprim
- Route
- Oral
- NDCs
- 53489-145, 53489-146
- FDA application
- ANDA071017
- Affected lot / code info
- Lot 6848501, EXP 04/2020
Why it was recalled
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.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 1,908 500-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-04-19
- FDA classified
- 2018-05-11
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0802-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.