FDA Drug recall D-0519-2019
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles…
- FDA Drug
- Class III
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class III recall of BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles… by Jubilant Cadista Pharmaceuticals, citing failed Dissolution Specifications; 9-monthstability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0519-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-28 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | n/a |
Product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Reason
Failed Dissolution Specifications; 9-monthstability timepoint
Identifiers
| code_info | a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc
FDA Drug · Class III · 2022-04-13 · Jubilant Cadista Pharmaceuticals - Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadis…
FDA Drug · Class I · 2022-04-06 · Jubilant Cadista Pharmaceuticals
All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2019%22
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