Reported Jan 31, 2018 · Terminated
Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing…
International Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: International Laboratories, Inc. · 6950 Bryan Dairy Rd Ste A · Seminole, FL · 33777-1606
Is this the product you have?
- 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 forInternational Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16
- Lot codes and dates
- Lot
117103AExp. 03/19
- Lot
- Amount recalled
- 13,403 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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