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Attention Members and Providers: MHS wants you to know about two recent drug recalls.

Date: 08/16/17

Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies:

PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15,2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto Syrup, both oral liquid docusate products – manufactured by PharmaTech. Labelers include Rugby, Major, Bayshore, Centurion, and Virtus. Please immediately check your medical supplies, quarantine any liquid drug products manufactured by PharmaTech, LLC and not administer them.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Pravastatin Sodium 40mg Tablets:

International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling.

  • The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.
  • The affected product is NDC# 54458-925-16; Lot# 115698A
  • International Laboratories, LLC is notifying its distributors and customer by letter and is arranging for return of all recalled products.
  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571066.htm