Ninjacof and Ninjacof A: Recall - potential Burkholderia cepacia contamination
FDA Sep 01, 2017
Ninjacof and Ninjacof A are used to temporarily relieve symptoms due to the common cold, allergic rhinitis or other respiratory allergies.
Centurion Labs is voluntarily recalling 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet 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 a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.
Products are sold in 473 mL bottles with the expiration date of 11/2018. The affected products are Ninjacof with Lot# 200N1601 (NDC 23359–032–16) and Ninjacof A with Lot# 201NA1601 (NDC 23359–033–16) and both were distributed within the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas. See press release for product photos.
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.
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Centurion Labs is voluntarily recalling 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet 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 a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.
Products are sold in 473 mL bottles with the expiration date of 11/2018. The affected products are Ninjacof with Lot# 200N1601 (NDC 23359–032–16) and Ninjacof A with Lot# 201NA1601 (NDC 23359–033–16) and both were distributed within the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas. See press release for product photos.
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.
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