Why it was recalled
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Product description
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Lot numbers, UPCs & expiration codes
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
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-0974-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 22, 2017
- FDA report date
- Jul 19, 2017
- Quantity
- 12480 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0974-2017, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 77606
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
- Postal code
- 21202-6174
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0974-2017
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 12480 bottles
- Termination date
- Jan 17, 2019
- Reason for recall
- Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2017