FDA Drug recall D-0224-2017
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Am…
- FDA Drug
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Am… by Inventia Healthcare Private, citing failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report ca….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0224-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Inventia Healthcare Private |
| Distribution | n/a |
Product
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Reason
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Identifiers
| code_info | Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0224-2017%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.