Why it was recalled
Failed Dissolution Specification
Product description
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Lot numbers, UPCs & expiration codes
Lot #: G602051, Exp. 12/2017
Where it was sold
Nationwide within the United States
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-0097-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 21, 2017
- FDA report date
- Dec 6, 2017
- Quantity
- 111,648 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0097-2018, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 78596
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: G602051, Exp. 12/2017
- Postal code
- 21202-6174
- Report date
- Dec 6, 2017
- Product type
- Drugs
- Recall number
- D-0097-2018
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 111,648 units
- Termination date
- Apr 15, 2019
- Reason for recall
- Failed Dissolution Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 28, 2017