Whole Foods Market recalls Trois Comtois Morbier cheese because of possible health risk

Contact

Consumer:
512-477-5566, extension 20060

Media:
Lindsay Robison
lindsay.robison@wholefoods.com
O: 512-542-3483 C: 512-520-7961 F: 512-499-6572

FOR IMMEDIATE RELEASE – July 31, 2013 – Whole Foods Market announces that it is recalling Trois Comtois Morbier cheese in the Mid Atlantic, Southwest, Northern California, Southern Pacific and Midwest regions. This cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Trois Comtois Morbier comes in wheels approximately 11 lbs. each, which are then cut and wrapped in varying weights and are labeled with a Whole Foods Market scale label.  Below is a list of how the cheese was labeled, including PLU code, according to the state in which it was sold. This recall includes all “best by” dates sold in Whole Foods Market stores in the states listed below.

State Labeled as PLU
Louisiana, Oklahoma, Texas Morbier Raw Milk 293358
Ohio, Virginia, Washington D.C. Morbier AOC Le Trois 293608
Illinois, Indiana, Michigan, Missouri, Nebraska, Wisconsin Morbier Raw Milk French Cheese 293358
Southern California, Hawaii, Arizona Morbier Raw Milk 293358
Northern California and Nevada (Reno store only) Morbier Les Trois Comtois 293608

To date, no illnesses have been reported to Whole Foods Market. This recall is in response to a recall by Trois Comtois in Poligny, France. Whole Foods Market is one of many retailers affected by this recall, as the product is also purchased by grocery stores, restaurants, and individual mail orders.

Signage is posted in all Whole Foods Market Mid Atlantic, Southwest, Northern California, Southern Pacific and Midwest stores to notify customers of this recall. Customers who have purchased this product from Whole Foods Market should discard it, and may bring in their receipt for a full refund. Consumers with questions may call 512-477-5566, extension 20060, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Daylight Time.

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Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance

Contact:
Consumer:
Dr. Wissam Alawieh, Pharm.D.
(800) 518-9831

FOR IMMEDIATE RELEASE – July 31, 2013 – Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level. There is a question of sterility assurance for the affected products raised by the FDA.

Microbial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening. Beacon Hill has not received any reports of adverse events related to this recall and to date, there is no evidence of contamination in the recalled products or any previously prepared products.

Below is the list of sterile injectable products compounded by Beacon Hill/Rxtra Solutions prescribed by physicians to individual patients according to their prescription order in alphabetical order, organized by Drug name and strength:

ACETYLCYSTEINE 100 MG/ML INJ SOLN APOMORPHINE HCL 3 MG/ML INJECTABLE ASCORBIC ACID ( CORN SOURCE) 500 MG/ML INJECTABLE
ASCORBIC ACID (NON CORN SOURCE) 500 MG/ML INJECTABLE B-12 REJUV 25 MG/ML INJECTABLE B-12/LIDOCAINE 25/10MG/ML INJECTABLE
B-COMPLEX/LIDO/B-12 25MG/ML INJECTABLE B-COMPLEX/LIDOCAINE 2% INJECTION INJECTABLE BI-TROPIN S-2 INJECTABLE
BUPRENORPHINE 0.3 MG/ML INJECTABLE BUPRENORPHINE 0.5 MG/ML INJECTABLE CALCIUM CHLORIDE 100 MG/ML
CALCIUM EDTA 200 MG/ML INJECTABLE CALCIUM EDTA 300 MG/ML INJECTABLE CHROMIUM 4 MCG/ML INJECTABLE
COPPER 0.4MG/ML INJECTABLE CYANOCOBALAMIN 1000 MCG/ML INJ SOLN CYCLOSPORIN (A) 2% (PF) AQUEOUS SUSP
DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE DEXPANTHENOL 250 MG/ML INJECTABLE DEXTROSE PF 50% INJECTABLE
DIAZEPAM 5MG/ML INJECTABLE DMPS P/F 50 MG/ML INJECTABLE DMSO 50% INJ 50 ML VIAL INJECTABLE
DUAL-TESTOSTERONE 10ML VIAL(COTTON SEED OIL) 200 MG/ML OIL INJ SOLN DUAL-TESTOSTERONE 2 ML VIAL 20 MG/ML OIL INJ SOLN DUAL-TESTOSTERONE 4 ML VIAL 50 MG/ML OIL INJ SOLN
DUAL-TESTOSTERONE 5 ML VIAL 50 MG/ML OIL INJ SOLN EDETATE DISODIUM 150 MG/ML INJECTABLE ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN
OXYTOCIN 10 UNITS/ML INJECTABLE ESTRIOL 5 MG/ML OIL INJ SOLN AMINO ACID III (COMPARE TO FREAMINE III) ALT. 8.5% INJECTABLE
ARGININE 100MG/ML INJECTABLE
FUROSEMIDE 10MG/ML INJECTABLE GLUTATHIONE 200 MG/ML (PF) INJ SOLN GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN
GLUTATHIONE/METHYL/LIDO 1 00/25/20 MG/ML INJ SOLN GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN GLYCINE 50 MG/ML INJECTABLE
GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE HYALURONIDASE 150U/ML INJECTABLE HYALURONIDASE 200U/ML INJECTABLE
HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE L-CARNITINE HCL 50 MG/ML INJECTABLE LIDOCAINE MDV 1% INJECTABLE
LIDOCAINE MDV 20 MG/ML INJECTABLE LIDOCAINE PF 20 MG/ML INJECTABLE LIPOIC ACID 100 MG/ML INJECTABLE
LIPOIC ACID 200 MG/ML INJECTABLE LIPO-PLEX INJECTABLE LIPO-PLEX/LIDOCAINE 2% INECTABLE INJECTABLE
L-TRYPTOPHAN 300 MG/ML INJECTABLE MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE MAGNESIUM SULFATE 50% INJECTABLE
MANGANESE SULFATE 0.1 MG/ML INJECTABLE MELOXICAM 10 MG/ML INJECTABLE MELOXICAM 5MG/ML INJECTABLE
METHYLCOBALAMIN (PF) 1 MG/ML INJ SOLN METHYLCOBALAMIN (PF) 25 MG/ML INJECTABLE METHYLCOBALAMIN 1 MG/ML INJ SOLN
METHYLCOBALAMIN 10 MG/ML INJ SOLN METHYLCOBALAMIN 25 MG/ML INJECTABLE METHYLCOBALAMIN 5 MG/ML INJ SOLN
METHYLPREDNISOLONE ACETATE 40 MG/ML INJECTABLE METHYLPREDNISOLONE ACETATE 80 MG/ML INJECTABLE MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE
MIC-CARN MAX (WITH METHYLCOBALAMIN) 15/100/50/1 MG/ML INJECTABLE MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE MIC-CARN MAX PLUS LIDOCAINE 15/100/50/1 MG/5MG/ML INJECTABLE
PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE PROCAINE P/F 20 MG/ML INJECTABLE
PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN PROGESTERONE 50 MG/ML OIL INJ SOLN PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP
PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE SELENIUM 400 MCG/ML INJECTABLE
SERMORELIN ACETATE 10 MG INJECTABLE SERMORELIN ACETATE 3 MG INJECTABLE SODIUM BICARBONATE PF 8.4% INJECTABLE
TACROLIMUS SOLUTION 0.02% OPHTHALMIC TEST. HYPOALLRGNC 200 MG/ML INJECTABLE TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE
TESTOSTERONE CYPIONATE 10 ML VIAL 100 MG/ML OIL INJ SOLN TESTOSTERONE CYPIONATE 2 ML VIAL 20 MG/ML INJECTABLE TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP
TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN TRIPLE-TESTOSTERONE 10 ML VIAL 250 MG/ML OIL INJ SOLN
TRIPLE-TESTOSTERONE 5 ML VIAL 200 MG/ML OIL INJ SOLN TRIPTROPIN PLUS INJECTABLE VITAMIN B- COMPLEX INJECTABLE
VITAMIN B-COMPLEX SL SOLTN VITAMIN B-COMPLEX (PF) INJECTABLE VITAMIN D 50,000 I.U./ML INJECTABLE
ESTRADIOL CYPIONATE 10 MG/ML OIL INJ SOLN ESTRADIOL CYPIONATE 40 MG/ML OIL INJ SOLN ESTRADIOL CYPIONATE 5 MG/ML OIL INJ SOLN
TRACE ELEMENTS-5 INJECTABLE NALBUPHINE HCL 20MG/ML INJECTABLE NANDROLONE DECANOATE 200 MG/ML OIL INJ SOLN
NANDROLONE DECANOATE 100 MG/ML OIL INJ SOLN ALPROSTADIL 100 MCG/ML INJ SOLN NALTREXONE 1 MG/ML INJECTABLE
NALTREXONE 200 MG/ML INJECTABLE HYDROCHLORIC ACID 10% INJ SOLN
ZINC SULFATE 1 MG/ML INJECTABLE ALPROSTADIL 50 MCG/ML INJ SOLN AMMONIUM MOLYBDATE 25 MCG/ML INJECTABLE
B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLUTION BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML INJECTABLE BI-MIX PHENTOLAMINE/PAPAVERIN E 1 MG/30 MG/ML INJECTABLE
BUPRENORPHINE 0.1/0.05 MG/ML CREAM DUAL-TESTOSTERONE 100 MG/ML OIL INJ SOLUTION DUAL-TESTOSTERONE 150 MG/ML OIL INJ SOLUTION
DUAL-TESTOSTERONE 200 MG/ML OIL INJ SOLUTION DUAL-TESTOSTERONE 50 MG/ML OIL INJ SOLUTION ESTRADIOL VALERATE W/LIDOCAINE 1% 40MG/ML OIL INJ SOLN
GLUTAMINE 100 MG/ML INJ SOLN H.C.G. (COMPOUNDED) 10,000 UNIT VIAL INJECTABLE H.C.G. (COMPOUNDED) 11,000 UNIT VIAL INJECTABLE
H.C.G. (COMPOUNDED) 12,000 UNIT VIAL INJECTABLE H.C.G. (COMPOUNDED) 5,000 UNIT VIAL INJECTABLE H.C.G. (COMPOUNDED) 8,000 UNIT VIAL INJECTABLE
HYDROGEN PEROXIDE 3% INJECTABLE HYDROCYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE
PARABEN WATER FOR INJECTION SODIUM HYDROXIDE 10% (W/V) WATER FOR INJECTION SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%
SODIUM PHOPHATE MONOBASIC/WATER FOR INJECTION 10% TESTOSTERONE CYPIONATE (COTTONSEED) 200 MG/ML OIL INJ SOLN TESTOSTERONE PROPRIONATE 100 MG/ML OIL INJ SOLN

Physicians prescribe these products to patients receiving IV solutions and hormone replacement therapy.

These products are packaged in clear or amber sterile injectable vials ranging in size of 1 ml to 100 ml containing liquid solution, suspension or lyophilized powder. The products are packaged in either individual patient prescription vials or single units in a cardboard box container. The products can be identified via the label format, which will include lot numbers initiating with code 01012013@1 to 07262013@99. The vials will contain a label indicating the drug name, strength, and quantity of product in the vial, the lot number with the codes indicated above, and a recommended use by date, product ingredients, storage instructions and the facility information and address. A sample vial label and prescription label is attached that includes the exact format for all products dispensed. The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield, Michigan.

Beacon Hill began notifying its customers on July 26th 2013 via telephone, and will begin initiating recall mailers including formal letters, and will continue to call its patients and providers, and schedule office visits to discuss with physicians further. Beacon Hill is arranging for return of all recalled products. Health care providers, hospital staff and patients should immediately check their inventory, identify products in their possession, which are being recalled, stop utilizing product and contact Beacon Hill Medical Pharmacy at 800.518.9831 to further assist with product replacement, continuity of care and further instructions on product return.

Beacon Hill recognizes FDA’s observations of sterile practices and 211 guidelines and has already initiated its facility upgrade in an effort to deliver at the highest manufacturing standard. Beacon Hill has initiated testing on products in the recall in quarantine in an effort to assess its validation process of prior sterility practices and will continue to cooperate with the FDA to establish 211guided standards of practice.

Beacon Hill is dedicated to this voluntary recall and has set up a task force of pharmacists and personnel ready to establish a transition for product replacement and urges patients to contact the pharmacy for any assistance.

Consumers with questions regarding this recall can contact Beacon Hill by calling 800.518.9831 during the business hours of 10 am and 6 pm eastern standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Purity First Health Products, Inc. Issues Nationwide Recall of Specific Lots of Healthy Life Chemistry B-50, Multi-Mineral and Vitamin C Products: Due to a Potential Health Risk

Contact

Consumer:
631-293-6525
632-293-6566
1-800-696-7017
FOR IMMEDIATE RELEASE – July 31, 2013 – East Northport, New York, Purity First Health Products, Inc. is voluntarily recalling two lots of Healthy Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral (200 capsules) and all lot numbers for Healthy Life Chemistry Vitamin C (200 capsules) to the consumer/user level. The B-50 capsules were tested by the U.S. Food and Drug Administration and have been found to contain Methasterone (schedule III controlled substance) and Dimethazine. The Multi-Mineral and Vitamin C capsules appear to indicate the presence of Dimethyltestosterone.

Risk Statement: The contaminated B-50, Multi-Mineral and Vitamin C capsules potentially could result in the following adverse events: liver injury, increased blood lipid levels, increased risk of heart attack and stroke, masculinization of women, shrinkage of the testicles, breast enlargement, infertility in males, and short stature in children. Not to mention fatigue, muscle cramping, and myalgia. The following products are marketed as Dietary Supplements and are packaged in white plastic bottles:

  • B-50, 100 capsule bottles, lot numbers F03Q and C02R
  • Multi-Mineral, 200 capsule bottles, lot number 12-829
  • Vitamin C, 200 capsule bottles, lot number E03Q

Products were distributed Nationwide via the internet, retail and through retail stores between July 2012 thru June 2013.

Immediately discontinue the use of this product and return it to the place of purchase. Consumers with questions should contact Purity First Monday through Friday from 10:00 am to 5:30 pm Eastern Standard Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S . Food and Drug Administration.

 

Source:  FDA.gov

 

2013  The NW Fire Blog