Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
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.
Lot numbers, UPCs & expiration codes
Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0661-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2020
- FDA report date
- Jan 22, 2020
- Quantity
- 3,989 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0661-2020, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 84677
- Address
- 615 N 1st St
- Code information
- Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020
- Postal code
- 38478-2403
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0661-2020
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 3,989 cartons
- Termination date
- Jul 14, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2020