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.
Reported: January 31, 2018 Initiated: January 12, 2018 #D-0233-2018
Product Description
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.
Reason for Recall
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Details
- Recalling Firm
- International Laboratories, Inc.
- Units Affected
- 9,052 cartons
- Distribution
- Nationwide in the USA
- Location
- Seminole, FL
Frequently Asked Questions
What product 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.. Recalled by International Laboratories, Inc.. Units affected: 9,052 cartons.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2018. Severity: Moderate. Recall number: D-0233-2018.
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