Reported May 10, 2017 · Terminated

Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473…

Akorn Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn Inc · 1925 W Field Ct · Lake Forest, IL · 60045-4862

Is this the product you have?

  • Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
Lot codes and dates
    • Lot# 348913
    • Exp.01/18
    • Lot# 349552
    • Exp.03/18
    • Lot# 349681
    • Exp. 03/18
    • Lot# 349683
    • Exp. 03/18
    • Lot# 349685
    • Exp. 03/18
    • Lot# 349687
    • Exp. 03/18
    • Lot# 349689
    • Exp. 03/18
    • Lot# 350636
    • Exp.03/18
Amount recalled
55,968 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 9, 2019 · Data as of Sep 19, 7:12 PM UTC

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