Reported Apr 1, 2020 · Terminated

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum…

Nostrum 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: Nostrum Laboratories Inc · 1800 N Topping Ave · Kansas City, MO · 64120-1228

Is this the product you have?

  • Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only
  • Manufactured byNostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01
Lot codes and dates
  • Lot
    • THE190501
    • Exp 11/2022
Amount recalled
4722 bottles

Where it was sold

Why it was recalled

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

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 Apr 1, 2022 · Data as of Sep 19, 7:59 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.