Why it was recalled
Failed Dissolution Specifications; during stability testing
Product description
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
Lot numbers, UPCs & expiration codes
Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
Where it was sold
Nationwide
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-0618-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 15, 2018
- FDA report date
- Apr 11, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0618-2018, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 79446
- Address
- 7 Oser Ave
- Code information
- Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
- Postal code
- 11788-3811
- Report date
- Apr 11, 2018
- Product type
- Drugs
- Recall number
- D-0618-2018
- Classification
- Class III
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Termination date
- Sep 15, 2021
- Reason for recall
- Failed Dissolution Specifications; during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2018