FDA Recalls Contrave Tablets Due to Punctured Bottle Complaints
Orexigen Therapeutics is recalling 95,296 bottles of Contrave extended-release tablets due to customer complaints of punctures in the bottles.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (punctures) without reported injuries or illnesses.
Plain-English summary
Orexigen Therapeutics, Inc. is recalling 95,296 bottles of Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets, 8 mg/90 mg, 120-count. The recall is being conducted due to customer complaints regarding punctures in the bottles.
The affected product is distributed nationwide in the USA. The specific lots involved are ZCXM, ZCXN, ZCXP, ZCXS, ZCXT, and ZCXV, with expiration dates ranging from November 2020. The product is a prescription-only medication.
Consumers with this product should contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
- Brand
- CONTRAVE
- Manufacturer
- Orexigen Therapeutics, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 95,296
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 (12)
- Lot #: ZCXM
- Exp 01NOV2020
- ZCXN
- Exp 02NOV2020
- ZCXP
- Exp 09NOV2020
- ZCXS
- 10NOV2020
- ZCXT
- Exp 13NOV2020
- and ZCXV
- Exp 17NOV2020
UPCs (1)
- 0351267890997
Distribution
Distributed nationwide across the United States.
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