Inventia Recalls Duloxetine Capsules Due to Broken Shells
Inventia Healthcare is recalling Duloxetine Delayed-Release Capsules 30 mg because capsule shells were found opening inside the bottles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves physical defects (broken shells) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Inventia Healthcare Private Limited is recalling Duloxetine Delayed-Release Capsules USP 30 mg, 30-count bottles, distributed by Cipia USA, Inc. The recall involves 46,848 capsules from batches 130/16/001, 130/16/002, and 130/16/003, all with an expiration date of 10/17. The product is distributed in the United States.
The recall was initiated due to reports that capsule shells were opening inside the bottles. Initial reports began on June 14, 2016, and approximately 22 reports have been received from pharmacies regarding batches 130/16/001 and 130/16/002. Batch 130/16/003 had not yet been distributed and is being recalled from the warehouse.
Consumers should stop using the affected capsules and contact their pharmacist or healthcare provider for guidance on returning the product or obtaining a replacement.
The recalled product
- 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
- Manufacturer
- Inventia Healthcare Private Limited
- Category
- Drug — Prescription Medication
- Affected units
- 46,848
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch # 130/16/001
- 130/16/002
- 130/16/003
- Exp. Date 10/17
Distribution
Distribution scope not specified by the agency.
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