Reported Dec 5, 2018 · Terminated

Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,…

Ascend Laboratories 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: Ascend Laboratories LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707

Is this the product you have?

    • Quetiapine Tablets USP 400 mg
    • 100 tablet bottles
    • Rx Only
  • Manufactured byAlkem Laboratories Ltd., Mumbai - 400 013, India
  • Distributed byAscend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01
  • UPC code3 67877-248-01 1
Lot codes and dates
    • Lot 7143908
    • exp Nov 2020
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance; metal shard found in tablet

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 Mar 30, 2020 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.