FDA Warns Consumers About Problems at Two Baltimore Pharmacies
August 10, 2008
THE U.S. FOOD AND DRUG ADMINISTRATION IS WARNING CONSUMERS WHO FILLED PRESCRIPTIONS AT THE MEDICINE SHOPPE PHARMACIES LOCATED AT 8035A LIBERTY ROAD AND 5900 REISTERSTOWN ROAD IN BALTIMORE THAT THEY MAY HAVE RECEIVED DRUGS THAT WERE EITHER EXPIRED OR SUSPECTED COUNTERFEIT. THE FDA IS PARTICULARLY CONCERNED BECAUSE A NUMBER OF THE DRUGS ARE FOR SERIOUS DISEASES AND COULD HAVE AN ADVERSE EFFECT ON TREATMENT.
Makers of Digitek Recall All Other Drugs
August 5, 2008
Actavis Totowa, makers of the recalled Digitek brand of digoxin, have announced a voluntary recall on all pharmaceutical drug products produced at their Little Falls, NJ drug manufacturing facility.
EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
July 31, 2008
CONTACT: EG LABS, LLC. EMAIL: EGLABS@GMAIL.COM
Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules
July 29, 2008
CONTACT: DEVINE DISTRIBUTION: 954-418-9510 G & N WORKS: 813 549-4177 RIZE2.COM: 813 549-4177 RIZE2.INFO: 954 418-9510
Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
July 25, 2008
AT THE REQUEST OF THE U.S. FOOD AND DRUG ADMINISTRATION, U.S. MARSHALS SEIZED NEARLY $74,000 WORTH OF XIADAFIL VIP TABLETS, LOTS 6K029 AND 6K209-SEI, DISTRIBUTED BY SEI PHARMACEUTICALS, INC. OF MIAMI, FLA. ALTHOUGH MARKETED AS A DIETARY SUPPLEMENT TO TREAT ERECTILE DYSFUNCTION (ED) AND FOR SEXUAL ENHANCEMENT, THESE LOTS REPRESENT AN ILLEGALLY MARKETED DRUG CONTAINING AN UNDECLARED INGREDIENT.
Roxane Laboratories, Inc. Initiates a Nationwide Recall of Two Lots of Sodium Polystyrene Sulfonate Suspension
July 16, 2008
CONTACT: JASON KURTZ 440-201-3668
FOR IMMEDIATE RELEASE — COLUMBUS, OHIO — JULY 14, 2008 — ROXANE LABORATORIES, INC. ANNOUNCED TODAY THAT IT IS CONDUCTING A NATIONWIDE VOLUNTARY RECALL OF TWO MANUFACTURING LOTS OF SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP, 15 G/60 ML UNIT DOSE BOTTLES (NDC 0054-0165-51; LOT 856396A EXP APRIL 2010, AND LOT 856693A EXP MAY 2010). SODIUM POLYSTYRENE SULFONATE SUSPENSION IS USED TO TREAT HYPERKALEMIA (AN ELEVATED BLOOD LEVEL OF THE ELECTROLYTE POTASSIUM).
ROXANE LABORATORIES’ NUMBER ONE PRIORITY IS FOR THE SAFETY OF PATIENTS WHO USE OUR PRODUCTS. A SAMPLE FROM PRODUCT LOT 856396A TESTED POSITIVE FOR A STRAIN OF YEAST, WHICH COULD POTENTIALLY AFFECT IMMUNOCOMPROMISED PATIENTS. ROXANE LABORATORIES BELIEVES THAT THIS MAY BE ATTRIBUTED TO YEAST CONTAMINATION IN ONE LOT OF HIGH-DENSITY POLYETHYLENE BOTTLES RECEIVED FROM A SUPPLIER. THERE ARE VARIOUS MANIFESTATIONS OF YEAST INFECTIONS. THE RISK OF DEVELOPING A YEAST INFECTION DEPENDS ON HOW IMMUNOCOMPROMISED THE PATIENT IS. ADDITIONALLY, THERE ARE A RANGE OF SYMPTOMS IN A YEAST INFECTION FROM THRUSH, SKIN RASH, AND BLOOD INFECTIONS (SEPS
Voluntary Nationwide Recall of Rize 2 The Occasion Capsules and Rose 4 Her Capsules
July 3, 2008
CONTACT: DEVINE DISTRIBUTION: 954-418-9510 G & N WORKS: 813 549-4177 RIZE2.COM: 813 549-4177     RIZE2.INFO: 954 418-9510        
Sage Products Inc. Recalls 2 Percent Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
July 1, 2008
CONTACT: KYM AFFINITO OR MIKE NYGREN 815-455-4700
FOR IMMEDIATE RELEASE — CARY, IL — JUNE 27, 2008 — AS A PRECAUTIONARY MEASURE, SAGE PRODUCTS ANNOUNCED A VOLUNTARY RECALL OF LIMITED LOTS OF 2% CHLORHEXIDINE GLUCONATE (CHG) CLOTH PATIENT PREOPERATIVE SKIN PREPARATION PRODUCT. TESTING OF BULK 2% CHG SOLUTION FROM AN OUTSIDE SUPPLIER WAS FOUND POSITIVE FOR BURKHOLDERIA CEPACIA (B. CEPACIA).
ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets
June 28, 2008
CONTACT: ANN MCBRIDE 1-800-321-1705
Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30)
June 4, 2008
CONTACT: CONSUMER HOTLINE (800) 638-6493
FOR IMMEDIATE RELEASE — MAY 30, 2008 — ABBOTT TODAY ANNOUNCED A VOLUNTARY WORLDWIDE RECALL OF TWO LOTS OF CALCILO XD® LOW-CALCIUM/VITAMIN D-FREE INFANT FORMULA WITH IRON POWDER IN 14.1-OUNCE CANS (400G). ONLY 14.1-OUNCE (400G) CANS ARE INVOLVED IN THIS ACTION. CALCILO XD® IS A LOW-CALCIUM AND VITAMIN D-FREE INFANT FORMULA THAT IS SPECIFICALLY DESIGNED FOR THE NUTRITION SUPPORT OF INFANTS AND CHILDREN WITH HYPERCALCEMIA (HIGH CALCIUM IN BLOOD). IT IS ONLY AVAILABLE BY SPECIAL ORDER.



