CLASS I Drug recall · Reported 20 Apr 2022 · FDA Enforcement Report
IDArubicin Hydrochloride Injection USP 5gm/ (1mg/mL) recalled
Teva Pharmaceuticals USA is recalling IDArubicin Hydrochloride Injection USP 5gm/ (1mg/mL) for intravenous use Single Dose Vial, distributed nationwide in the US. The recall was initiated on 29 Mar 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0765-2022
- FDA event ID
- 89876
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Mar 2022
- FDA classified
- 11 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Mar 2022 | Recall initiated by company | |
| 11 Apr 2022 | Classified by FDA | +13 days |
| 20 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Which lots are affected?
Lot #: 31329657B, Exp. Date 08/2023
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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