Reported Nov 4, 2020 · Terminated

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc.,…

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?

  • Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only
  • Repackaged byRemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Lot codes and dates
  • Lot NumbersJ0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
Amount recalled
79/30 count blister cards

Where it was sold

Why it was recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

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 Feb 24, 2021 · Data as of Sep 19, 8:08 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.