Reported Dec 28, 2016 · Terminated
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private…
Inventia Healthcare Private Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inventia Healthcare Private Limited · F1- F 1/1, Additional Ambernath MIDC · Thane, N/A · N/A
Is this the product you have?
- Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only
- Manufactured byInventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA
- Distributed byCipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
- Lot codes and dates
Batch # 130/16/001130/16/002130/16/003Exp. Date 10/17
- Amount recalled
- 46,848 delayed-release capsules
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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