Reported Aug 17, 2022 · Terminated

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint…

Teva Pharmaceuticals USA Inc.

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: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd
  • in Romania BySindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Lot codes and dates
  • Lot
    • FE22001A
    • Exp 01/2024
Amount recalled
4162 cartons

Where it was sold

Why it was recalled

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

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 Apr 12, 2023 · Data as of Sep 19, 5:55 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.