Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Idarubicin Hydrochloride Injection 20 mg/20 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Affected NDC
0703-4156-11
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0703-4156-11
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0734-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Teva Pharmaceuticals USA
All 2021 recalls
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Other sterility / contamination recalls from 2021
All sterility / contamination recalls
Class II · Moderate risk
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Lack of Assurance of Sterility
Class II · Moderate risk
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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