Recalls / Class II
Class IID-0661-2020
Product
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 lot / code info
- Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 3,989 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-01-07
- FDA classified
- 2020-01-13
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0661-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.