FDAFDA · Food and drugs·Recall number D-0224-2017
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
Published December 28, 2016 · Recall initiated: October 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Inventia Healthcare Private Limited
- Distributor
- United States
- Lot
- Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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