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.
Product description
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
Lot numbers, UPCs & expiration codes
Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
Where it was sold
United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0224-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 46,848 delayed-release capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inventia Healthcare Private Limited
Original FDA data
Every field from FDA enforcement report D-0224-2017, exactly as published.
Show all FDA fields
- City
- Thane
- Status
- Terminated
- Country
- India
- Event ID
- 75642
- Address
- F1- F 1/1, Additional Ambernath MIDC
- Address (line 2)
- Ambernath (east)
- Code information
- Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0224-2017
- Classification
- Class II
- Recalling firm
- Inventia Healthcare Private Limited
- Product quantity
- 46,848 delayed-release capsules
- Termination date
- Jun 1, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- United States
- Recall initiation date
- Oct 19, 2016
- Initial firm notification
- Telephone
- Center classification date
- Dec 22, 2016