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Behavior Modification Drug, Kosher Cake Recalled

Recall-SidebarTwo lots of a behavior modification drug used by patients with a variety of psychological conditions and a popular Passover dessert have been recalled by their manufacturers.

 

 

Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).


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TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. In January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.

While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor. As it relates to RISPERDAL® and risperidone, there have been no reported serious adverse events caused by the presence of TBA.

The RISPERDAL® lot - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.

Package Description

NDC Code

Lot Number

Expiry

RISPERDAL® (risperidone) Tablets
3mg Bottles of 60 Tablets

50458-330-06

0GG904

May 2012

Risperidone Tablets
2mg Bottles of 60 Tablets

50458-593-60

OIG175

August 2012

 

RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.

RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania.

RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The company does not anticipate a product shortage resulting from this action.

Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with RISPERDAL® 3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the Medical Information Recall Line at 1-800-634-8977 (Monday - Friday, 9 am - 5 pm ET). Information can also be found on www.risperdal.com1 and www.patriotpharmaceuticals.com2.

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

Online: www.fda.gov/medwatch/report.htm3

Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/medwatch/getforms.htm4. Mail to address on the pre-addressed form.

Fax: 1.800.FDA.0178

We conducted an investigation involving our suppliers to evaluate the potential source of this TBA issue. This investigation revealed that some of the wooden pallets used by one of our suppliers in its warehouse were contaminated with TBA. In addition, some of the packaging components manufactured by our supplier were exposed to these pallets. We have initiated a deeper investigation to determine the potential impact of these findings to other products. We also are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

The voluntary recall, being implemented with the knowledge of the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated two odor-related reports.

RISPERDAL® 3mg Tablets are yellow and imprinted with "JANSSEN" on one side and R3 on the other. Risperidone 2mg Tablets are orange and imprinted "PATR" on one side and R2 on the other.

Cinderella Sweets, of Woodmere, NY is recalling the following Kosher for Passover item because it contains eggs:

SHABTAI GOURMET BRAND
Cindy’s Scrumptious Chocolate Chip Pound Cake--16 oz
UPC# 8-50097 00152-3 All lots

People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product. Consequently, we are recalling these items from the market. A review of product labeling revealed a notation stating “egg free” on the pound cake product listed above when in fact the products contains egg. Although the ingredient statement clearly indicates egg in the contents, and eggs are identified in the Allergen statement (in bold type) it still poses a potential health hazard. The recalled cake, described above, was distributed nationwide to retail stores.

This product is in a white 8"x5.75"x2" window cookie box with the SHABTAI logo within a planet "Saturn" type logo, with a bakery type red & white twine border imprint. Consequently, we are recalling Cindy's Scrumptious Chocolate Chip Pound Cake from the market.

No illnesses have been reported to date in connection with this technical problem with the printing of the boxes. The recall was initiated after it was discovered that the egg-containing product was distributed in packaging that made a claim to be egg free. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging supply chain.

Production of the product has been suspended until the FDA and the company is certain that the problem has been corrected. This recall is being made with the knowledge of the US Food and Drug Administration.

Consumers who have purchased these products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at info@cinderellasweets.com or call 516.374.7976 Monday thru Thursday 9:00am to 5:00pm.