Qualitest Pharmaceuticals has announced that it is recalling specific lots of hydrocodone bitartrate and aacetaminophen tablets and phenobarbital tablets. The recall comes after a 60-count bottle of hydrocodone bitartrate and aacetaminophen tablets was found incorrectly labeled as phenobarbital tablets.
This mislabeling could cause patients to unintentionally ingest hydrocodone and aacetaminophen tablets instead of the intended dose of phenobarbital. This mix-up could lead to serious adverse events. Patients who accidentally ingest hydrocodone could experience respiratory depression, central nervous system (CNS) depression, coma and death. The risks are especially high for opioid naive patients and those who are on other CNS depressants. Unintentionally ingesting acetaminophen could lead to liver toxicity in patients who are taking other acetaminophen-containing medications, patients with liver dysfunction and people who consume three or more alcoholic drinks a day. Missing doses of phenobarbital could result in loss of seizure control.
Affected lots of the medications were distributed to wholesale and retail pharmacies between September 21, 2010 and December 29, 2010. To learn more and view affected lot numbers, click here.
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