Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Romidepsin Injecton
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Affected NDC
0703-4004-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0703-4004-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0309-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 impurity / degradation recalls from 2021
All impurity / degradation recalls
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class III · Low risk
Carvedilol Tablets
Failed Impurities/Degradation Specifications
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