FDA Recalls IDArubicin Injection for Particulate Matter Contamination
Teva Pharmaceuticals is recalling IDArubicin Hydrochloride Injection vials due to the presence of silica and iron oxide particulate matter. The recall affects nationwide distribution within the United States.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the FDA, which mandates a minimum severity score of 4. Although no reported illnesses or deaths are mentioned, particulate contamination in an injectable medication represents a serious potential hazard.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use in 5mL single-dose vials due to the presence of particulate matter.
The affected product is Lot #31329657B with an expiration date of August 2023, National Drug Code (NDC) 0703-4154-11. Approximately 1565 vials have been distributed nationwide throughout the United States.
The product was found to contain silica and iron oxide particulate matter.
Healthcare providers and patients with vials from the affected lot should consult with their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Injectable Chemotherapy
- Affected units
- 1,565
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 31329657B
- Exp. Date 08/2023
Distribution
Distributed nationwide across the United States.
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