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.
Reported: January 22, 2020 Initiated: January 7, 2020 #D-0661-2020
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 3,989 cartons
- Distribution
- Nationwide in the USA.
- Location
- Pulaski, TN
Frequently Asked Questions
What product 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.. Recalled by AVKARE Inc.. Units affected: 3,989 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2020. Severity: Moderate. Recall number: D-0661-2020.
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