Home / Recalls / International Laboratories, Inc. / D-0102-2018

D-0102-2018 Class I Terminated

Recalled by International Laboratories, Inc. — St Petersburg, FL

Recall Details

Product Type
Drugs
Report Date
December 13, 2017
Initiation Date
August 7, 2017
Termination Date
May 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82056 bottles

Product Description

Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16

Reason for Recall

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

Distribution Pattern

U.S.A. nationwide and Puerto Rico

Code Information

Lot # 115698A, Exp 02/19

Other recalls by International Laboratories, Inc.

  • D-0234-2018 Class II — Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 ta (January 12, 2018)
  • 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)