Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Pravastatin Sodium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
54458-0927-16
Compare with the code on your package — it is the most precise check available.
Drug: Pravastatin Category: Cholesterol Medication
- Recalling firm
- International Laboratories, Inc.
- NDC code
- 54458-927-16
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0233-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pravastatin recalls
See all
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets 80mg
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications
Other recalls by International Laboratories, Inc.
All 2018 recalls
Class II · Moderate risk
Pravastatin Sodium Tablets
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Class I · High risk
Clopidogrel Tablets
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Class I · High risk
Pravastatin Sodium Tablets
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
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