IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Reported: April 20, 2022 Initiated: March 29, 2022 #D-0765-2022
Product Description
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Reason for Recall
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 1565 vials
- Distribution
- Nationwide within the United States
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 1565 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 20, 2022. Severity: Critical. Recall number: D-0765-2022.
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