Reported Jul 3, 2019 · Terminated

Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American…

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 Ste A · Columbus, OH · 43217-1188

Is this the product you have?

  • Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only
  • Packaged and Distributed byAmerican Health Packaging, Columbus
  • Ohio 43217 NDC Blister Card68084-440-11
  • NDC Carton68084-440-01
Lot codes and dates
  • Lot
  • expiry
    • Lot 172669
    • exp 05/31/2019
    • Lots 175872
    • 177086
    • exp 09/30/2019
    • Lot 179047
    • exp 12/31/2019
    • Lot 182584
    • exp 07/31/2020
Amount recalled
16,698 cartons

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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 30, 2020 · Data as of Sep 19, 8:05 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.