FDA Drug recall 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 On…
- FDA Drug
- Class III
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class III recall of 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 On… by Invagen Pharmaceuticals, citing failed Dissolution Specifications; during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0619-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-15 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specifications; during stability testing
Identifiers
| ndc | 69097-877-02 |
|---|---|
| ndc | 69097-877-03 |
| ndc | 69097-877-07 |
| ndc | 69097-877-12 |
| ndc | 69097-878-02 |
| ndc | 69097-878-03 |
| ndc | 69097-878-07 |
| ndc | 69097-878-12 |
| ndc | 69097-879-02 |
| ndc | 69097-879-03 |
| ndc | 69097-879-07 |
| ndc | 69097-879-12 |
| code_info | a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.