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Medication Safety Alerts

Pravastatin sodium 40 mg tablets Voluntary Recall

8/10/2017

On August 10, 2017, the United States Food and Drug Administration (FDA) issued a notice about a voluntary recall of pravastatin sodium 40 mg tablets distributed byInternational Laboratories.This recall was issued because one bottle of pravastatin sodium 40 mg tablets contained bupropion hydrochloride XL 300 mg tablets. Taking bupropion instead of pravastatin could cause side effects.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 115698A. To see if you have affected product, please check the lot number. The lot number is located on the left hand side of the manufacturer’s label by the barcode. If your product is not from lot number 115698A, it is not affected by this recall. Pravastatin sodium 40 mg tablets are light-green, round-shaped tablets with “TEVA” on one side and 7202 on the other. If your tablets match this description, you are not affected by this recall. If your product is from lot number 115698A or if your prescription was not filled in the manufacturer’s bottle, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: This product not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently taking pravastatin sodium 40 mg tablets and have questions regarding this recall, please call your doctor or call International Laboratories at 727‑322‑7146, Monday through Friday, 8:00 am to 5:00 pm (ET) or visit www.internationallabs.com.

You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.

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