Antibiotic recalled on a "super powerful" dosage - serious side effects possible, warns the FDA
The affected bottles were distributed nationally, according to the recall notice.
Contrary to over -the -counter products , we can only have prescription drugs, including antibiotics when doctors deem them necessary. In many cases, they are the best and fastest way to launch an infection and help a patient feel better again. But now, the U.S. Food & Drug Administration (FDA) warns that an antibiotic has been recalled on an accidental "super powerful" dose that they can contain.
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In an alert published on March 27, the agency announced that New Jersey Amneaux pharmaceuticals , LLC, fired four lots from its vancomycin hydrochloride for an oral solution, USP, 250 mg / 5 ml. The affected product is packed in 80 ml bottles with the number of Lot 22613003A; 150 ml bottles with lot numbers 22613004a and 22613005a; and 300 ml bottles with lot number 22613005b. All bottles are labeled with the expiration date "09/2025".
Depending on the recall notice, antibiotic "is administered orally for the treatment of enterocolitis caused by Staphylococcus aureus (including strains resistant to methicillin) and pseudomembrane colitis associated with antibiotics caused by It's hard “The products were distributed nationally between November 9, 2023 and February 20, 2024.
Adult patients are only supposed to receive a maximum of 2 grams of medication per day. However, a manufacturing error led the on-reproductive packages with up to four grams of the solution. Since some patients taking the drug may have inflammatory problems with their intestines which more likely make "significant systemic absorption", they could be at risk of serious side effects, especially if they also suffer from a kidney disease or a failure.
Until now, no cases of unfavorable medical events have been reported linked to the recalled product. According to the recall notice, consumers who currently have the drug must carefully inspect their bottle and stop using it immediately if it is stamped with one of the lot numbers.
They should then contact the company for more information on the return of the product by calling on 1-833-582-0812 from Monday to Friday from 8:00 a.m. to 5:00 p.m. EASTERN Standard Time (East), or E-mail [Protected by e-mail] . They should also contact their doctor if they believe they have known health problems by taking antibiotics.
It is not the only time recently that dosage problems have led to a reminder. In February, the FDA announced that Nordic Naturals had pulled a lot of his Nordic Naturals Baby's Vitamin D3 Liquid , 0.76 fl. OZ (22.5 ml), 400 IU (10mcg) D3 Vitamin D supplements from stores. The opinion indicates that an "manufacturing error" had led to "a high dose of vitamin D3" which could cause potentially serious side effects in babies, in particular vomiting, loss of appetite, increased thirst, A frequent urination and "the inability to prosper".
