Multi event Drug Recall Enforcement Report Class III voluntary initiated by InvaGen Pharmaceuticals, Inc., originally initiated on 03-15-2018 for the 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 The product was recalled due to failed dissolution specifications; during stability testing. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0618-2018 | 03-15-2018 | 04-11-2018 | Class III | N/A | 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 | Failed Dissolution Specifications; during stability testing | Terminated |
| D-0619-2018 | 03-15-2018 | 04-11-2018 | Class III | N/A | 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 | Failed Dissolution Specifications; during stability testing | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 69097-877 | Bupropion Hydrochloride (sr) | Bupropion Hydrochloride | Tablet, Extended Release | Oral | Cipla Usa Inc., | Human Prescription Drug |
| 69097-878 | Bupropion Hydrochloride (sr) | Bupropion Hydrochloride | Tablet, Extended Release | Oral | Cipla Usa Inc., | Human Prescription Drug |
| 69097-879 | Bupropion Hydrochloride (sr) | Bupropion Hydrochloride | Tablet, Extended Release | Oral | Cipla Usa Inc., | Human Prescription Drug |
