Drug recall D-0618-2018
Product
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
Reason for recall
Failed Dissolution Specifications; during stability testing
Lots and codes
Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
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.,