Orexigen Recalls Contrave Tablets Due to Container Packaging Defect
Orexigen Therapeutics is recalling 18,895 bottles of Contrave extended-release tablets due to a container packaging defect. The affected lot is ZYCY with an expiration date of 04/11/2021.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to a container packaging defect.
Plain-English summary
Orexigen Therapeutics, Inc. is recalling 18,895 bottles of Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets. The product is distributed in 120-count bottles and is available by prescription only. The specific lot affected is ZYCY, with an expiration date of 04/11/2021.
The recall was initiated due to a container packaging defect. The agency has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences or death.
Consumers who have this specific lot of Contrave should stop using it and contact their healthcare provider or pharmacist for further instructions. The product was distributed within the United States.
The recalled product
- Product
- CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
- Brand
- CONTRAVE
- Manufacturer
- Orexigen Therapeutics, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 18,895
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 (2)
- Lot #: ZYCY
- Exp. 04/11/2021
UPCs (1)
- 0351267890997
Distribution
Distribution scope not specified by the agency.
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