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Nationwide Recall of Cholesterol Medication Due to Manufacturing Problems


Tens of thousands of bottles of cholesterol medication have been recalled nationwide due to serious manufacturing and quality issues.

Zydus Pharmaceuticals (USA) Inc. and AvKARE have both issued recalls for their respective medications, citing concerns that could affect the drugs’ potency. According to separate releases from the Food and Drug Administration (FDA), these recalls are part of ongoing efforts to ensure patient safety.

Zydus Pharmaceuticals is recalling approximately 22,896 bottles of Icosapent Ethyl capsules. Manufactured by Softgel Healthcare and distributed in 120-count bottles, this medication has been classified as subpotent. Federal officials have warned that oxidation caused by leaking capsules has reduced the drug’s strength. Consequently, using this medication “may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” as stated in the recall notice.

FDA ROLLS BACK ‘RED TAPE’ IN MOVE ALIGNED WITH TRUMP PUSH TO SPEED UP NEW CURES


Tens of thousands of bottles of cholesterol medication have been recalled nationwide. (Getty Images)

The FDA has classified this recall as Class II, indicating that the products involved “might cause temporary, medically reversible health problems.” Serious consequences are considered “remote.”

FDA RECALLS BLOOD PRESSURE MEDICATION OVER CHOLESTEROL DRUG CONTAMINATION

In addition, AvKARE has recalled thousands of bottles of Rosuvastatin Tablets, which are packaged in 50-tablet unit dose cartons. This recall is also due to manufacturing issues that affect the medication’s efficacy.


Zydus Pharmaceuticals (USA) Inc. and AvKARE have recalled their respective medications over manufacturing and quality issues. (Getty Images)

Federal officials have indicated that the affected medicine does not dissolve as intended once ingested, which could lead to ineffective treatment.

Both recalls have been classified as Class II by the FDA, emphasizing the importance of addressing these issues promptly.

A pharmacy tech pulls medication from a shelf inside a pharmacy

Both recalls are being classified as Class II. (George Frey/Bloomberg via Getty Images)

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Both recalls are still considered ongoing, and consumers are advised to stay informed about any updates.


Tens of thousands of bottles of cholesterol medication have been recalled nationwide due to serious manufacturing and quality issues.

Zydus Pharmaceuticals (USA) Inc. and AvKARE have both issued recalls for their respective medications, citing concerns that could affect the drugs’ potency. According to separate releases from the Food and Drug Administration (FDA), these recalls are part of ongoing efforts to ensure patient safety.

Zydus Pharmaceuticals is recalling approximately 22,896 bottles of Icosapent Ethyl capsules. Manufactured by Softgel Healthcare and distributed in 120-count bottles, this medication has been classified as subpotent. Federal officials have warned that oxidation caused by leaking capsules has reduced the drug’s strength. Consequently, using this medication “may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” as stated in the recall notice.

FDA ROLLS BACK ‘RED TAPE’ IN MOVE ALIGNED WITH TRUMP PUSH TO SPEED UP NEW CURES


Tens of thousands of bottles of cholesterol medication have been recalled nationwide. (Getty Images)

The FDA has classified this recall as Class II, indicating that the products involved “might cause temporary, medically reversible health problems.” Serious consequences are considered “remote.”

FDA RECALLS BLOOD PRESSURE MEDICATION OVER CHOLESTEROL DRUG CONTAMINATION

In addition, AvKARE has recalled thousands of bottles of Rosuvastatin Tablets, which are packaged in 50-tablet unit dose cartons. This recall is also due to manufacturing issues that affect the medication’s efficacy.


Zydus Pharmaceuticals (USA) Inc. and AvKARE have recalled their respective medications over manufacturing and quality issues. (Getty Images)

Federal officials have indicated that the affected medicine does not dissolve as intended once ingested, which could lead to ineffective treatment.

Both recalls have been classified as Class II by the FDA, emphasizing the importance of addressing these issues promptly.

A pharmacy tech pulls medication from a shelf inside a pharmacy

Both recalls are being classified as Class II. (George Frey/Bloomberg via Getty Images)

GET FOX BUSINESS ON THE GO BY CLICKING HERE

Both recalls are still considered ongoing, and consumers are advised to stay informed about any updates.