Reported Jul 24, 2013 · Terminated

QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health…

American Health Packaging

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: American Health Packaging · 2550 John Glenn Ave · Columbus, OH · 43217-1188

Is this the product you have?

  • QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx
  • Packaged and Distributed byAmerican Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Lot codes and dates
  • Lot 122600 Exp. 03/14
Amount recalled
19060 blister cards

Where it was sold

  • Nationwide

Why it was recalled

Failed 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 Aug 21, 2013 · Data as of Sep 19, 6:28 PM UTC

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