Frozen pizza, makeup books for pre-teens, injectable drugs and sexual enhancement supplements are on the list of today’s recalls by the U.S. Food and Drug Administration.
FROZEN PIZZA – Kashi is recalling approximately 11,000 cases of frozen pizzas, including Mediterranean Thin Crust Pizza, Roasted Vegetable Thin Crust Pizza, and Mushroom Trio and Spinach Thin Crust Pizza due to possible plastic fragments in an ingredient in the pizza crusts.
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The impacted products include the following individually packaged pizzas:
- Kashi Mediterranean Thin Crust Pizza packaged in a 12.7 ounce box and marked with UPC Code 1862732905 3 and Best If Used Before date of either May10 12NU, May18 12NU, or May19 12NU;
- Kashi Roasted Vegetable Thin Crust Pizza packaged in a 12.2 ounce box and marked with UPC Code 1862737342 1 and Best If Used Before date of either May09 12NU or May14 12NU;
- Kashi Mushroom Trio and Spinach Thin Crust Pizza packaged in an 11.9 ounce box and marked with UPC Code 1862737344 5 and Best If Used Before date of May17 12NU.
No other Kashi frozen pizzas or other products are included in the recall, and no consumer complaints have been reported. The products were distributed nationwide through U.S. retail grocery stores.
“People who buy Kashi trust the quality and safety of our foods,” said David DeSouza, general manager. “We apologize for this situation and are working closely with our suppliers and retail customers to resolve it quickly.”
Consumers with questions or who would like a replacement may contact the Kashi Consumer Response Center at 877.864.3521 Monday – Friday from 8 a.m. to 6 p.m. Eastern time, or visit www.Kashi.com1.
MAKEUP BOOKS – MGA Entertainment of Van Nuys is recalling 6,200 units of the Bratz Makeup Design Sketch Book. This product has the potential to be contaminated with Staphylococcus warneri and Staphylococcus intermedius. MGA is recalling products produced between November 5, 2010 and February 25, 2011. MGA has ceased production and distribution of this product.
S. warneri rarely causes disease in humans. Wounds in the eye increase risk of infection and may result in symptoms such as pain and decreased visual acuity. S. intermedius is a very rare cause of infection in humans and risks are typically associated with veterinary exposures. For certain individuals, such as those with compromised immune systems, introduction into the eye by either microorganism may result in infection, which, if left untreated, may lead to sight-threatening complications.
To date there have been no reports of illness or injury associated with this product.
The Makeup Design Sketch book was distributed nationwide and sold through retail stores and e-commerce web sites.
Product can be identified by the batch code and/or item number printed on the back cover of the sketch book. The UPC for product number 504788 is: 0-35051-50478-8
Through finished product testing, elevated levels of bacteria was found in the eye shadow portion of this product.
Consumers should discontinue use of this product. For information on how to obtain a refund for your purchase, phone MGA Customer Service at 1 800 222-4685 Monday-Saturday, 8 AM-6 PM CST.
METHYLDOPATE HCL INJECTIBLES – American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:
Methyldopate HCL Injection, USP, 250 mg/5 mL (50mg/mL), 5 mL Single Dose Vial
NDC # 0517-8905-10, Lot # 0152, Exp Date March, 2012.
PLEASE NOTE: This recall, initiated on June 6, 2011 to the User or Consumer Level, is for Lot # 0152 only. No other lots of Methyldopate HCL Injection, USP are subject to this voluntary recall.
This voluntary recall was initiated because some of the vials of this lot contained translucent visible particles consistent with glass delamination. The glass particles (flakes) ranged in size from <50 microns to 200 microns.
Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of Methyldopate HCL Injection, USP is administered to patients. American Regent has not received any reports of adverse events related to this recall.
Methyldopate HCL Injection, USP is used to treat hypertension, when parenteral medication is indicated.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Emergency Rooms, Clinics, and other healthcare facilities and providers should not use American Regent Inc., Methyldopate HCL Injection, USP, 250mg/5mL, Single Dose Vials, with Lot # 0152, for patient care and should immediately quarantine any product for return.
American Regent is notifying its distributors and consumers by e-mail, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.
American Regent will credit accounts for all returned Methyldopate HCL Injection, USP, 250mg/5mL, Single Dose Vials, with Lot # 0152. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.
Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.
Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at firstname.lastname@example.org by fax to (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS OR FAX OR PHONE.
Adverse reactions or quality problems experienced with the use of this product/lot may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.
As is standard practice, and as stated in the Methyldopate HCL Injection, USP, Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”
Methyldopate HCL Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
Source: Luitpold Pharmaceuticals, Inc.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
SEXUAL ENHANCEMENT SUPPLEMENTS – Global Wellness, LLC. Hollywood, FL is conducting a voluntary nationwide recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN to the consumer level. The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers. The product is distributed as a bottle containing six (6) blue colored capsules per package. The label on the packaging lists the company name Global Wellness, LLC, Hollywood Florida. Only Lots 809013 and 806030 are covered in this recall.
The company has been informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis conducted by FDA for Lots 809013 and 806030 found that the product contains sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. Silenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
No illnesses have been reported to Global Wellness, LLC to date in connection with these products.
With an abundance of caution, Global Wellness, LLC is voluntarily recalling only lots 809013 and 806030 of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN. This recall does not affect sales and distribution of SLIM XTREME GOLD™ and GELSLIM™.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm1], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm2] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Consumers with questions may contact the company at (954) 922-1133 Monday through Friday from 9:00am to 4:00pm EST for instructions on the return process.
Global Wellness, LLC apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action.
Global Wellness, LLC, remains committed to product quality and integrity of all its products and the company is working closely with the FDA in the recall process. We deeply value the trust you have placed in Global Wellness, LLC and regret any inconvenience this product recall may have caused. This voluntary recall does not affect the SLIM XTREME GOLD™ and GELSLIM™ herbal slimming capsules distributed by Global Wellness, LLC.