Dutasteride Capsules recall: Impurity Out of Spec
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.
Why was Dutasteride Capsules recalled?
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020
- 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.
- Recalling firm
- AVKARE Inc.
- Quantity
- 3,989 cartons
- Distribution
- Nationwide in the USA.
- Recall date
- January 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)