Home / Recalls / International Laboratories, Inc. / D-0234-2018

D-0234-2018 Class II Terminated

Recalled by International Laboratories, Inc. — Seminole, FL

Recall Details

Product Type
Drugs
Report Date
January 31, 2018
Initiation Date
January 12, 2018
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,403 cartons

Product Description

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 for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.

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 Pattern

Nationwide in the USA

Code Information

Lot: 117103A, Exp. 03/19

Other recalls by International Laboratories, Inc.

  • D-0233-2018 Class II — Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 ta (January 12, 2018)
  • D-0472-2018 Class I — Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: Inter (January 4, 2018)
  • D-0102-2018 Class I — Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: (August 7, 2017)