Drug recall D-0619-2018
Product
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
Reason for recall
Failed Dissolution Specifications; during stability testing
Lots and codes
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
Recall details
- Recalling firm
- InvaGen Pharmaceuticals, Inc., Hauppauge, NY
- Quantity
- N/A
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2018
- Terminated
- September 15, 2021
Related products
- Bupropion Hydrochloride (sr) – drug information
- NDC 69097-878 Bupropion Hydrochloride (sr) · Bupropion Hydrochloride 150 mg/1 · Cipla USA Inc.,
- NDC 69097-879 Bupropion Hydrochloride (sr) · Bupropion Hydrochloride 200 mg/1 · Cipla USA Inc.,
- NDC 69097-877 Bupropion Hydrochloride (sr) · Bupropion Hydrochloride 100 mg/1 · Cipla USA Inc.,