Why it was recalled
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Product description
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
Lot numbers, UPCs & expiration codes
Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
Where it was sold
Nationwide, Alaska, Hawaii, and Puerto Rico.
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-1435-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 26, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 107,880 (60 ct bottle)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Scientific, Inc
Original FDA data
Every field from FDA enforcement report D-1435-2016, exactly as published.
Show all FDA fields
- City
- Arlington
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 73419
- Address
- 2100 Rd To Six Flags Dr
- Code information
- Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
- Postal code
- 76011
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1435-2016
- Classification
- Class III
- Recalling firm
- Apotex Scientific, Inc
- Product quantity
- 107,880 (60 ct bottle)
- Termination date
- Jun 15, 2022
- Reason for recall
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
- Distribution pattern
- Nationwide, Alaska, Hawaii, and Puerto Rico.
- Recall initiation date
- Jan 26, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2016