Multi-event August 2017 FDA Recall Ninjacof by Centurion Labs, Llc
This Multi-event Class II drug recall was voluntarily initiated by Centurion Labs, Llc on August 22, 2017 for the product Ninjacof. The FDA reported the reason for recall as microbial contamination of non-sterile products; potential b. cepacia contamination. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1141-2017
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
08-22-2017
09-20-2017
621 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Centurion Labs, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
09-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-033-16
Batch or Lot Expiration Information
Lot# Lot: 201NA1601 Exp. 11/2018
Recall Number: D-1140-2017
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
08-22-2017
09-20-2017
4149 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Centurion Labs, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
09-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16
Batch or Lot Expiration Information
Lot# Lot: 200N1601 Exp. 11/2018
