Recalls / Class III
Class IIID-0097-2018
Product
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
- Brand name
- Duloxetine
- Generic name
- Duloxetine
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 68180-294, 68180-295, 68180-296, 68180-297
- FDA application
- ANDA090694
- Affected lot / code info
- Lot #: G602051, Exp. 12/2017
Why it was recalled
Failed Dissolution Specification
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 111,648 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2017-11-21
- FDA classified
- 2017-11-28
- Posted by FDA
- 2017-12-06
- Terminated
- 2019-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.