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Drug Recalls News

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A lack of sterility assurance has prompted Akorn Inc. to recall more than 60,000 bottles of phenylephrine hydrochloride ophthalmic solution, 2.5%. According to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report, the recall announcement followed “out-of-specification…
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Alkermes Inc. is recalling more than 16,000 Vivitrol (naltrexone for extended-release injectable suspension) kits because of incorrect needle packaging, according to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report.   The recall is “due to 1-inch needles being placed…
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Torrent Pharma Inc. is recalling several losartan products after the detection of trace amounts of an unexpected impurity, according to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report.  “The impurity detected is N-Methylnitrosobutyric acid (NMBA),” stated a September…
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Pfizer Inc. is recalling 7824 bottles of ethosuximide capsules, 250 mg (NDC 59762-2250-2), that were distributed throughout the United States by Greenstone LLC. According to the October 2, 2019, US Food and Drug Administration (FDA) Enforcement Report, the product label includes an incorrect…
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A defective delivery system has prompted a Class I recall of 25-mcg, 50-mcg, 75-mcg, and 100-mcg doses of Natpara (parathyroid hormone) for injection. According to the October 2, 2019, US Food and Drug Administration (FDA) Enforcement Report, there is a risk of rubber stopper particles clogging the…
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Akorn Inc. is recalling 10,543 tubes of lidocaine hydrochloride jelly, 2%.   Akorn “reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product,” according to the October 2, 2019, US Food and Drug Administration (FDA) Enforcement…
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By Reuters Staff (Reuters) - The U.S. Food and Drug Administration declined to approve AstraZeneca Plc's combination therapy to treat smoker's lung, the drugmaker said on Tuesday. AstraZeneca said that it will work closely with the FDA regarding next steps, including submitting results from an…
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West-Ward Columbus Inc. is recalling 32,347 bottles of oxcarbazepine oral suspension because the drug failed to meet impurity/degradation specifications, according to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report.  The recall affects oxcarbazepine oral suspension…
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Torrent Pharma Inc. is recalling 2472 bottles of anagrelide capsules. According to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report, “high out-of-specification results for impurities [were] detected during routine stability testing.”  The recall affects anagrelide…
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Aurolife Pharma is recalling fexofenadine hydrochloride tablets distributed by multiple outlets under a variety of brands throughout the United States. According to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report, the tablets failed to meet impurity/degradation…
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