SULFAMETHOXAZOLE AND TRIMETHOPRIM

Generic: SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sun Pharmaceutical IndustriesManufacturer

ORALRoute

SULFAMETHOXAZOLEActive Substance

1986-08-25Original Approval

SULFAMETHOXAZOLE AND TRIMETHOPRIM is FDA application ANDA071017, sponsored by SUN PHARM INDUSTRIES. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2021-07-07

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Auro

Presence of Foreign Substance- Potential of metal contamination.

Class II2022-04-13

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 09

cGMP deviations: Temperature abuse

Class II2025-08-18

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packagin

Class I2025-06-02

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial co

Class II2011-09-27

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfameth

Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg

Class II2020-08-10

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distribu

Presence of Foreign Substance: product complaints were received by the firm for the presence of meta

Class II2025-09-02

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packagi

Class II2018-04-19

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc

Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethopr

Class II2025-09-02

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packagi

Class II2025-08-20

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-3

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packagi

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Recalls

Top Reported Reactions