Hikma Pharmaceuticals USA Inc. is recalling 97,890 vials of Buprenorphine HCl Injection (0.3 mg/mL, 1 mL vials) because the drug was found to be sub-potent during stability testing. This means the medication may not contain the full required amount of the active ingredient needed to be effective. Affected products were distributed nationwide in the U.S. and are intended for intramuscular or intravenous use only.
A sub-potent medication may not provide the intended level of pain relief or therapeutic effect, which could lead to inadequate treatment for patients depending on this medication. No specific injuries or adverse events have been reported to date.
Return for refund and consult healthcare provider
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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Sources: FDA iRES · Raw API Response
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