Reported Mar 27, 2019 · Terminated

Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by:…

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?

    • Valsartan Tablets USP 160 mg
    • 100 Tablets (10 x 10) per Unit Dose Blisters
    • Rx Only
  • Packaged and Distributed byAmerican Health Packaging, Columbus
  • Ohio 43217 (Individual Dose NDC
    • 60687-139-11
    • Carton NDC#: 60687-139-01)
Lot codes and dates
    • Lot 179791
    • Mar 2020
Amount recalled
3337 cartons

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

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.

Free recall alerts

Get alerted about new American Health Packaging recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 9, 2020 · Data as of Sep 19, 5:05 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.