Reported Nov 28, 2012 · Terminated

Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited,…

Dr. Reddy's Laboratories, 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: Dr. Reddy's Laboratories, Inc. · 200 Somerset Corporate Blvd Fl 7th · Bridgewater, NJ · 08807-2862

Is this the product you have?

  • Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets
  • Mfd By
    • Dr. Reddy's Laboratories Limited
    • Bachepalli - 502 325
    • India NDC 55111-249-05
Lot codes and dates
  • Lot C203090 Exp.03/14
Amount recalled
1512 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

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 10, 2013 · Data as of Sep 19, 6:05 PM UTC

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