ISSUE: Insight Pharmaceuticals, LLC recalled one lot (lot #11G075, UPC Code 6373673005, 34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis).
BACKGROUND: Nostrilla Nasal Decongestant was distributed nationwide through normal retail outlets and pharmacies. The product comes in a 1/2 ounce, plastic bottle marked with an expiration date of 05/2014 stamped on the side.
RECOMMENDATION: Consumers who purchased "Nostrilla Decongestant, lot #11G075" are urged to return the product and contact the company at 1-877-546-9059 Monday through Friday from 9 am-5 pm EST time zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/21/2011 - Press Release - Insight Pharmaceuticals]
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