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Class II Statin Recall


February 01, 2018

Dosage concerns have prompted International Laboratories Inc. to voluntarily recall 2 lots of 10-mg and 20-mg pravastatin sodium tablets, USP. According to the January 31, 2018, US Food and Drug Administration (FDA) Enforcement Report, bottles from the lots may contain tablets of both strengths.

The recall affects:

  • 9052 cartons of 10-mg pravastatin sodium tablets in 30-count bottles (NDC 54458-927-16) from lot 117093A (Exp. 6/19), and
  • 13,403 cartons of 20-mg pravastatin sodium tablets in 30-count bottles (NDC 54458-926-16) from lot 117103A (Exp. 3/19).

International Laboratories initiated the recall January 12, 2018. The FDA designated it a Class II recall January 24, 2018. The classification communicates that use of the tablets could cause temporary or reversible adverse effects. The likelihood of serious harm is remote.

The recalled pravastatin tablets were distributed across the United States. Pravastatin is a prescription HMG-CoA reductase inhibitor used to lower cholesterol and triglycerides in the blood.

Jolynn Tumolo


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