The Ritedose Corporation Announces the Voluntary Nationwide Recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL Due to Mislabeled Unit Dose Vials
Contact:
The Ritedose Corporation
803-935-3995
recall@ritedose.com
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials). This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this recall.The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. This product was distributed nationwide and Puerto Rico.
Administration of this defective product could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death. There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used resulting in an administered amount that is 5 times the recommended dose. In the hospital setting, the vials are often not accompanied by the rest of the packaging, making it more likely that such a dosing error could occur. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.
The Ritedose Corporation is working cooperatively with the U.S. FDA to implement a nationwide recall as quickly and efficiently as possible.
Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc.). Wholesalers and retailers should return the product to the following address:
Attn: RECALL
8025 Howard Street
Spartanburg, SC 29303
For more information concerning this recall contact The Ritedose Corporation directly at phone: 803-935-3995 Monday through Friday 8am to 5 pm EST or by e-mail: recall@ritedose.com.
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 regular mail or by fax.
- Online:http://www.fda.gov/MedWatch/report.htm9
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10 . Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
PRock Marketing, LLC Issues a Voluntary Nationwide Recall of All weight loss formulas and variation of formulas of Reduce Weight Fruta Planta/Reduce Weight Dietary Supplement.
Contact:
Raquel McCalla
President of PRock Marketing, LLC
Frutaplanta.com
1-877-225-1009
PRock Marketing, LLC located in Central Florida an authorized US distributor of the Authentic Formula Fruta Planta has been informed by the Food and Drug Administration (FDA) that the weight loss dietary supplements sold and marketed contains an undeclared drug ingredient. The FDA lab analysist of the dietary supplements found the Authentic Formula Fruta Planta to contain 15.4 mg of Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons. No illnesses or injuries have been reported to the company to date in connection with these products. The FDA advises against taking ALL Formulas of Reduce Weigh Fruta Planta/Reduce Weight products. These products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
All lots of the Fruta Planta and Reduced Weight Fruta Planta dietary supplement products are being recalled. All these products contain the active pharmaceutical ingredient Sibutramine:
- Fruta Planta; 30 Capsules/Box
- Reduce Weight Fruta Planta; 30 capsules/Box; 30 capsules/Bottle
- Reduce Weight Fruta Planta; 30 capsules/ Pink Box;
- Reduce Weight Fruta Planta; 30 capsules/Box With GMP Sticker
- Reduce Wieght Fruta Planta; 30 Capsules/Box
- Reduce Wieght; 30 Capsules/Box
PRock Marketing, LLC has taken this voluntary action because it is committed to providing accurate information to all consumers and is concerned for the health and safety of all users of Fruta Planta. PRock Market, LLC is working with the FDA in the recall process. We sincerely regret any inconvenience the recall may cause customers.
Consumers are advised to destroy the above products or return them to the companys address in Central, Florida. Consumers with questions may contact frutaplanta.com Monday through Friday 10:00 am to 4:30 pm at 877-225-1009 EST.
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.
- Online:www.fda.gov/medwatch/report.htm 9
- Regular Mail : use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm 10. Mail to address on the pre-addressed form.
- Fax : 1-800-FDA-0178
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