Reported Oct 11, 2023 · Terminated

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American…

Amerisource Health Services LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Amerisource Health Services LLC · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188

Is this the product you have?

  • HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only
  • Distributed byAmerican Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01
  • Individual Dose NDC68084-447-11
Lot codes and dates
    • Lot#: 1007002
    • Exp 12/31/2023
Amount recalled
3,344 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 16, 2024 · Data as of Sep 19, 5:07 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.