Why it was recalled
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Product description
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Lot numbers, UPCs & expiration codes
Lot: 18103 Exp. 11/18
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-0055-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 274 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0055-2018, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 78240
- Address
- 615 N 1st St
- Code information
- Lot: 18103 Exp. 11/18
- Postal code
- 38478-2403
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0055-2018
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 274 cartons
- Termination date
- Mar 11, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2017