Agency classClass IIOur severity:Severe FDA (Drugs)·D-1141-2017·Announced 2017-09-20

Centurion Labs Recalls Ninjacof-A Oral Solution Due to Microbial Contamination

Centurion Labs is recalling Ninjacof-A oral solution due to potential B. cepacia contamination. Consumers should stop using the product and return it to the pharmacy.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (microbial contamination) are categorized as Severe (Score 4), as they are not Class I but involve significant health risks.

Plain-English summary

Centurion Labs, LLC is recalling 621 bottles of 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. The recall is due to microbial contamination, specifically the potential for B. cepacia contamination in the non-sterile product.

The affected product is identified by Lot 201NA1601 with an expiration date of 11/2018. The product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it immediately and return it to the pharmacy or point of purchase for a refund or replacement. If you have questions about the recall, you may contact Centurion Labs, LLC.

The recalled product

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
Manufacturer: Centurion Labs, LLC
Category: Drug — Oral Solution
Hazard: microbial-contamination
b-cepacia
Affected units: 621

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot: 201NA1601 Exp. 11/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Centurion Labs, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Centurion Labs, LLC

See all →

Severe
Centurion Labs Recalls Ninjacof Oral Solution Due to Potential B. cepacia Contamination
FDA (Drugs) · 2017-09-20

Same hazard · microbial contamination