# FDA recall D-0224-2017

> **Inventia Healthcare Private Limited** · Class II · drug recall initiated 2016-10-19.

## 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 for recall

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.

## Distribution

United States

## Key facts

- **Recall number:** D-0224-2017
- **Recalling firm:** Inventia Healthcare Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-19
- **Report date:** 2016-12-28
- **Termination date:** 2017-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Thane, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2017

## Citation

> AI Analytics. FDA recall D-0224-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0224-2017. Source: US FDA. Licensed CC0.

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