4 days ago
Urinary tract infection drug recalled. Tablets could be tainted and deadly
Three lots of a drug designed to treat various urinary tract infections have been recalled because the white round tablets might have black spots from microbial contamination.
The spotting of spots 'was reported in a product quality complaint,' Amneal Pharmaceuticals said in its FDA-posted recall notice about Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg.
As for what problems this might cause, Amneal's notice said: 'Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.'
Sulfamethoxazole/Trimethoprim is used for UTIs caused by a broad list of strains, among which are E. coli; middle-ear infections in children; streptococcus pneumoniae aka pneumococcus, which the Cleveland Clinic says can cause pneumonia, sepsis or bacterial meningitis; and 'traveler's diarrhea.'
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What exactly has been recalled?
Recalled tablets with 400 mg of Sulfamethoxazole and 80 mg Trimethoprim went to wholesalers and distributors around the nation from Dec. 4 through May 15. If you have these tablets but got them before Dec. 4, you're safe.
Bottles in lot No.s AM241019 and AM241020 are 100-count bottles. Bottles in lot No. AM241019A have 500 tablets.
If you're taking these drugs, for instructions on returning them or to ask questions about this recall, contact Amneal at 833-582-0812, Monday through Friday, 8 am. to 5 p.m., Eastern time; email sulfamethoxazole-trimethoprim-recall@ or fax to 631-983-2595.
If you experience any medical problems, tell a medical provider. Then inform the FDA's MedWatch program, either online or by downloading a form, then faxing it to 800-332-0178. If you can't download a form, call 800-332-1088 to ask for a form.
Then you should report the problem to Amneal at 877-835-5472, Monday through Friday, 8 a.m. to 6 p.m., Eastern time or by emailing DrugSafety@
