FDAFDA · Food and drugs·Recall number D-0619-2018
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) 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
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
- a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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