Pravastatin Sodium Tablet USP Recall [US]

US FlagUS/Silver Spring: Pravastatin Sodium Tablet USP Recall [US]International Laboratories, LLC recalls certain batch/lots of Pravastatin Sodium Tablets USP 40 mg due to suspected mislabeling, inappropriate administration of Bupropion Hydrochloride XL 300 mg and consequential risk of nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision, seizures as well as possible allergic reactions that could be life threatening, all serious health hazards that require immediate medical intervention. FDA: http://ht.ly/lnXJ30exOUK

Direct link: https://www.fda.gov/Safety/Recalls/ucm571019.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following drugs are subject to this recall:

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Rugby Enteric Coated Aspirin Tablet Recall [US]

US FDA RecallUS/Silver Spring: Advance Pharmaceutical recalls some Rugby label Enteric Coated Aspirin Tablets due to incorrect drug hazard. FDA: http://ht.ly/mheMS

Direct link: http://www.fda.gov/Safety/Recalls/ucm357909.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the recalled drug product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablet with an NDC 0536-3086-41 and a UPC 3 0536-3086-41 9. The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026 with Expiration Date 01-2015. The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major Pharmaceuticals) distributed the product nationwide to wholesalers and retailers.

According to the FDA, consumers who self-administer the recalled Enteric Coated Aspirin Tablets 81 mg may, in fact, be inadvertently taking Acetaminophen 500 mg due to a mislabeling error. If this occurs, it may cause severe liver damage to those who take other drugs containing Acetaminophen, consumers who take three (3) or more alcoholic drinks every day or those who have liver disease.

The label directions instruct patients to take four (4) to eight (8) tablets every four (4) hours, but not more than 48 tablets in any 24 hour period. Consumers who take 48 tablets daily of the mislabeled and recalled drug product may be in fact be ingesting up to 24,000 mg of Acetaminophen. This is approximately six (6) times the maximum recommended daily dose of Acetaminophen (4,000 mg).

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