FDA recall D-0233-2018

International Laboratories, Inc. · Class II · drug

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-01-12
Report date: 2018-01-31
Termination date: 2019-05-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Seminole, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2018