CLASS II Drug recall · Reported 31 Jan 2018 · FDA Enforcement Report
Pravastatin Sodium Tablets, USP, 10 mg recalled
International Laboratories is recalling Pravastatin Sodium Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 12 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0233-2018
- FDA event ID
- 78939
- Recalling firm
- International Laboratories, Seminole, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 24 Jan 2018
- Reported
- 31 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Cholesterol Medication
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 24 Jan 2018 | Classified by FDA | +12 days |
| 31 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Pravastatin Sodium Tablets, USP, 10 mg recalled?
Yes. International Laboratories recalled Pravastatin Sodium Tablets, USP, 10 mg on 12 Jan 2018. The recall is Class II and its status is Terminated. Recall number D-0233-2018.
Why was it recalled?
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Which lots are affected?
Lot: 117093A, Exp. 06/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from International Laboratories
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clopidogrel Tablets, USP 75 mg recalled by International Laboratories | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20 mg recalled | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS I | Pravastatin Sodium Tablets, USP, 40 mg recalled | International Laboratories | Packaging Defects | Nationwide |
Other Pravastatin recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 80mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |