Alvogen, Inc. has recalled 9,696 cartons of Buprenorphine and Naloxone Sublingual Film (2mg/0.5mg), a medication used to treat opioid use disorder. This recall was initiated because the medication was found to be subpotent, meaning it contains lower levels of the active ingredients than required. Using a low-potency version of this medication may lead to ineffective treatment of withdrawal symptoms or cravings, potentially increasing the risk of relapse. The affected products were distributed nationwide in the USA and come in pouches containing 30 sublingual films.
The medication is out of specification for its active ingredients, buprenorphine and naloxone. This lower-than-intended dosage could result in sub-therapeutic treatment for patients managing opioid dependence, leading to inadequate control of symptoms.
Pharmacy return and refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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