Class II · Moderate risk
Dutasteride 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Dutasteride Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
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
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
Affected NDC
50268-0282-13
Compare with the code on your package — it is the most precise check available.
Drug: Dutasteride
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-282-13
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0661-2020 · 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 Dutasteride recalls
See all
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Other recalls by AVKARE Inc.
All 2020 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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