The Recall Desk

FDA (Drugs) recall action 78939

International Laboratories, Inc. recalled 2 products on 2018-01-31

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-01-31
Critical
0
Units
22,455

Why these products were recalled

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Drugs)··2018-01-31

    International Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, 20 mg, because bottles may contain 10 mg tablets. Patients should contact their healthcare provider.

    Product
    Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-01-31

    Pravastatin Sodium Tablets Recalled Due to Foreign Tablet Presence

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets 10 mg because bottles may contain 20 mg tablets.

    Product
    Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
    Category
    Distribution
    0 states