FDAFDA · Food and drugs·Recall number D-0618-2018
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
Published April 11, 2018 · Recall initiated: March 15, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; during stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION HYDROCHLORIDE (SR)
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Distributor
- Nationwide
- UPC
- 0369097879037
- Lot
- Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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