The US Food and Drug Administration (FDA) announces that Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601; NDC 23359-032-16) and 1 lot of Ninjacof A (Lot# 201NA1601; NDC 23359-033-16) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in Pharmatech, a FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. Use of a product that may contain B. cepacia, could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life threatening in the at-risk patient population.
Ninjacof and Ninjacof A are used to temporarily relieve symptoms due to the common cold, allergic rhinitis or other respiratory allergies and the products are sold in 473 mL bottles with the expiration date of 11/2018. The affected products were distributed within the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm572873.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by Vilvet and Pharmatech. Related news was previously issued by FDA and Macau Health Bureau, and was posted on the Drug Office website since 16 Jul 2016, with the latest update posted on 17 Aug 2017. The Department of Health (DH) will remain vigilant on update of the incident and recall issued by FDA and other overseas drug regulatory authorities.
Ends/Thursday, Aug 24, 2017
Issued at HKT 15:00
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