Clavulanic Acid

Despite the U.S. government shutdown, which has run through the entirety of October and into the first half of November, the FDA has continued to issue weekly enforcement reports keeping the public apprised of key recalls for pharmaceuticals and other products. Since the start of the month, several drug recalls have entered the FDA’s periphery, affecting products ranging from hospital drugs and potassium deficiency injections to antibiotics and a generic medicine for attention-deficit/hyperactivity disorder (ADHD).Despite the U.S. government shutdown, which has run through the entirety of October and into the first half of November, the FDA has continued to issue weekly enforcement reports keeping the public apprised of key recalls for pharmaceuticals and other products.Two of the latest product pulls in the U.S.—initiated for separate medicines from Otsuka ICU Medical and Fresenius Kabi in November—have received postings on the FDA’s dedicated drug recall page, which previously had not been updated since late August.Fresenius’ recall is among the latest and concerns three lots of the drugmakers’ famotidine injection, which is used to treat certain hospitalized patients with pathological hypersecretory conditions or intractable ulcers. The drug is also used as a short-term alternative to oral drugs for several conditions like duodenal ulcers and gastroesophageal reflux disease, Fresenius explained.Fresenius took its recall action after observing out-of-spec endotoxin results on certain reserve samples from a single batch of the hospital med, according to a company announcement on the FDA’s website.Elevated endotoxin levels in a drug can cause “severe systemic reactions” like sepsis and septic shock, with severe responses potentially triggering “inflammatory and life-threatening” immune responses, Fresenius warned in the communique.At the time of the recall notice’s posting, Nov. 7, Fresenius said it had received “[n]on-serious adverse event reports” that could be tied to the out-of-spec results observed for one product lot.“These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking,” the company explained, adding that it had not received any side effect reports tied to the second or third lots in the recall.The three recalled batches were set to expire between August and October of next year, the company’s announcement states. Just a few days prior to Fresenius’ recall, Otsuka ICU Medical—a recent joint venture between Japan’s Otsuka and U.S.-based ICU Medical to bolster the American IV solutions market—revealed on Halloween that it was yanking two lots of injectable potassium chloride, which is used to treat potassium deficiency in people for whom oral replacements aren’t viable.Otsuka ICU Medical kicked off the recall after identifying a mislabeled batch of its 20 milliequivalent (mEq) dose that identified the product as the 10mEq presentation, attributing the slipup to a “manufacturing issue.”Patients who receive a higher potassium chloride dose by mistake run the risk of an overdose, which can lead to hyperkalemia, the Otsuka JV cautioned in its recall notice. Severe hyperkalemia following a large intravenous overdose can cause neuromuscular dysfunction like muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypertension, cardiac dysrhythmias or death from cardiac arrest, Otsuka ICU explained.The FDA posted the notice to its website on Nov. 3. At the time Otsuka ICU Medical issued the alert, the company said it had not received any adverse event reports tied to the labeling snafu.While the Fresenius and Otsuka ICU recalls carry serious potential risks for patients who receive the products in question, many of the other product pulls issued in recent days appear to pose less of an immediate health threat.Sun Pharmaceutical, for instance, is recalling two lots of the ADHD generic lisdexamfetamine dimesylate at the 10-mg dose after reviewing failed dissolution results in a 12-month stability test. Dissolution refers to process through which a drug is released from a dosage form like a pill, ointment or, in Sun’s case, capsule.The recall is taking place nationwide, according to last week’s FDA enforcement report, which has coded the event Class II, indicating that use of the recalled product could cause “temporary or medically reversible adverse health consequences.”Sun’s product is a generic of Takeda’s popular stimulant ADHD medication Vyvanse.Elsewhere, Teva Pharmaceuticals recently embarked on a recall of one lot of amoxicillin and clavulanate potassium for oral suspension—a combination antibiotic referencing Augmentin—after the clavulanate potassium component was found to be subpotent.The recall affects 4,680 cartons of the generic antibiotic, according to the FDA’s latest enforcement report, which notes that the drug was manufactured by Teva’s Canadian subsidiary for the U.S. market. The suspect lot was distributed across three states—Mississippi, Ohio and California—according to the posting.Teva launched the generic Augmentin recall just a few days after initiating a separate recall of more than 500,000 bottles of the popular blood pressure drug prazosin. That earlier recall was triggered after testing found that certain 1-, 2- and 5-mg prazosin capsules contained traces of the cancer-linked impurity N-nitroso prazosin impurity C, which registered “above acceptable intake limits."Nitrosamines are a group of chemicals that can form in a variety of conditions, including during the manufacturing or storage of drugs. Many nitrosamines are carcinogenic.