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:

  • Pravastatin Sodium Tablet USP, 40 mg packaged in bottles of 30 tablets

Please consult the photograph above for details of the food’s packaging, design and retail presentation. One (1) additional image of the recalled Pravastatin Sodium Tablets can be found on the Web site above.

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, one batch/lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30 count bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets. International Laboratories, LLC has reported no complaints or reports of medical illnesses or harmful effects have been received by press time.

Drug Background:

  • Pravastatin Sodium Tablets USP 40 mg are an HMG-CoA reductase inhibitor (commonly referred to as Statins) indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
  • Bupropion Hydrochloride Extended-Release Tablets (“XL”) 300 mg are an Aminoketone Antidepressant, indicated for the treatment of major depressive disorder (“MDD”) and prevention of seasonal affective disorder (SAD) in children, adolescents, young adults and adults.

The Pravastatin Sodium Tablets were delivered to distribution centers in Arkansas, Georgia and Indiana and distributed to retail stores in Arkansas, Alabama, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, Ohio, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin.

==> Never stop taking your prescription medications, including Statins, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any food, return it to your retailer for refund or toss it out in your household garbage, making sure neither small children nor household pets can access the suspect food.

If you believe you have purchased or have in your possession any of the drug drugs, please do not consume them directly nor use them as an ingredient in another drug preparation. Instead, return the Pravastatin Sodium Tablets to the pharmacist where you purchased it for a full refund.

If you have any questions about this recall, please contact International Laboratories at 1-727-322-7146 from 8:00 AM to 5:00 PM Eastern Standard Time.

==> To see other recalls and notifications caused by suspected drug contamination or adulteration, please search for “drug” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 9099-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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