Reported Nov 12, 2014 · Terminated

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only,…

Sun Pharma Global 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: Sun Pharma Global Inc. · P.O. Box 12850 · Dubai, N/A · N/A

Is this the product you have?

  • Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Lot codes and dates
  • Batch NumberJKM3855A Mfg
  • Date06/25/2013 Exp
  • Date05/31/2015
  • Batch NumberJKM3855B Mfg
  • Date06/25/2013 Exp
  • Date05/31/2015
  • Batch NumberJKM7265A Mfg
  • Date12/25/2013 Exp
  • Date11/30/2015
  • Batch NumberJKM7265B Mfg
  • Date12/25/2013 Exp
  • Date11/30/2015
Amount recalled
68194

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specifications; 12 month stability 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 May 6, 2015 · Data as of Sep 19, 7:12 PM UTC

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