Reported Apr 10, 2013 · Terminated

Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC…

Dr Reddys Laboratories Tennessee LLC

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: Dr Reddys Laboratories Tennessee LLC · 201 Industrial Dr · Bristol, TN · 37620-5413

Is this the product you have?

    • Amoxicillin for Oral Suspension
    • 125mg/5mL
    • a) 80 mL (NDC 43598-222-80)
    • b) 100mL
    • (NDC 43598-222-52)
    • c)150 mL (NDC 43598-222-53) bottles
    • Rx only
    • Dist
  • ByDr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807
Lot codes and dates
    • Lot #s: a) T200112
    • b) T200103
    • T200113
    • c) T200104
    • T200114
Amount recalled
4236 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

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 Oct 1, 2013 · Data as of Sep 19, 6:24 PM UTC

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