The Recall Desk
HighFDA (Drugs)·D-1059-2022·Announced 2022-06-15

Prescription Antibiotic Tablets Recalled Due to Temperature Abuse

McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a prescription antibiotic due to cGMP deviations from temperature abuse. No adverse health consequences have been reported. The recall is classified as High because it involves a risk-of-harm scenario (potential drug instability) in the absence of reported injuries.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets, USP (800mg/160mg), a prescription antibiotic, distributed nationwide. The recall was initiated due to cGMP deviations that resulted from temperature abuse during manufacturing.

No adverse health consequences have been reported in association with this recall.

Patients currently taking this medication should contact their healthcare provider or pharmacist regarding whether their supply may be affected. Healthcare providers and pharmacies should consult the distribution dates provided in McKesson's recall notification letters to determine whether they received affected product.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Prescription Antibiotic
Hazard
  • temperature-abuse
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

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