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Oxycodone on Packaging Line Leads to Recall of Betaxolol
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
KVK-Tech is voluntarily recalling one lot of Betaxolol Tablets, USP 10 mg, which is a beta blocker used to treat patients with hypertension and also used to treat glaucoma. The company is making the recall as a precautionary measure after one tablet Oxycodone HCl tablet 5 mg was found on the packaging line of Betaxolol.
KVK has not received any reports of foreign tablet in any bottle of Betaxolol.
Betaxolol has a warning on its label about the possibility of a slowing in the heart rate in elderly patients. This effect could be increased by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might be have compromised heart and lung function that is also likely to be exacerbated by an opioid, the company said.
The affected Betaxolol has a lot number of 17853A and has an expiration date of June 2027. The batch was distributed nationwide to wholesalers and retailers.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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