Reported Jul 22, 2020 · Terminated

Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA…

RemedyRepack 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: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571

Is this the product you have?

    • Carbamazepine 200 mg Tablets
    • 100-unit dose tablets per box
    • Rx only
  • Repackaged by
    • RemedyRepack Inc
    • Indiana
    • PA 15701
    • NDC 70518-2489-00 for box
    • 70518-2489-01 per unit dose
Lot codes and dates
  • Lot #: B0796217-020920, Exp
  • Date02/28/2021
Amount recalled
498 tablets

Where it was sold

Why it was recalled

FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

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 Sep 14, 2020 · Data as of Sep 19, 7:55 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.