Medmonitor

Endo, Inc. announced a voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Various Clonazepam products with the lot number 550176501 may contain the incorrect strength and National Drug Code (NDC) code, thought the blister strips and tablets inside the product pack reflect the correct strength for the lot. Clonazepam is used to treat anxiety and seizures. Consuming a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.

Hospira, Inc., a Pfizer company, is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection Carpuject Units due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. In the event that impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment. Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. The impacted lot numbers are HJ3965 and HJ8546. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.

The FDA received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk of potentially serious allergic-type reactions to sulfite-containing compounded drugs. Health care professionals and patients may be unaware of sulfite allergies or sensitivities. Sulfites are substances that may be added to certain drug products as preservatives, to help prevent the active drug ingredient from breaking down and becoming less effective. Sulfites may cause allergic-type reactions in susceptible people, especially patients with asthma. Allergic-type reactions may include anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. So far, reports have included complaints of pink eye, itchy eyes, swollen eyelids, and respiratory failure. FDA-approved prescription drugs containing sulfites are required to include a warning statement in the product labeling. However, compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, quality or labeling prior to marketing.

Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30 mg Extended-Release tablets and one lot of morphine sulfate 60 mg Extended-Release tablets, as the labels for these two products were mixed-up. Morphine sulfate is an opioid product for the management of severe pain. Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low.