Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Azacitidine for Injection 100mg/vial Lyophilized Powder Recalled by Teva Pharmaceuticals USA Inc Due to Subpotent Drug - Out of specification (OOS) result...

Date: July 22, 2022
Company: Teva Pharmaceuticals USA Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA Inc directly.

Affected Products

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Quantity: 4162 cartons

Why Was This Recalled?

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

Where Was This Sold?

Distributed in Ohio

About Teva Pharmaceuticals USA Inc

Teva Pharmaceuticals USA Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report