Reported Jul 9, 2014 · Terminated

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles.…

Caraco Pharmaceutical Laboratories, Ltd.

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: Caraco Pharmaceutical Laboratories, Ltd. · 1150 Elijah McCoy Dr · Detroit, MI · 48202-3344

Is this the product you have?

  • Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles
  • Distributed byCaraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202
  • Manufactured atSun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count
  • Bottle NDC
    • 41616-758-83
    • 90-Count
  • BottleNDC 41616-758-81
Lot codes and dates
  • 30
  • Count BottleLot #: JKL5054A
  • Expiry
    • 08/2014
    • Lot #: JKM2305A
  • Expiry03/2015. 90
  • Count BottleLot #: JKL5054B
  • Expiry
    • 08/2014
    • Lot #: JKM2305B
  • Expiry03/2015
Amount recalled
26,530 30-Count Bottles; 14,597 90-Count Bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specifications: Stability results found the product did not meet the drug 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 May 6, 2015 · Data as of Sep 19, 7:57 PM UTC

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