Centurion Labs Recalls Ninjacof Oral Solution Due to Potential B. cepacia Contamination
Centurion Labs is recalling Ninjacof 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 (such as microbial contamination) are categorized as Severe (Score 4), particularly when specific pathogens like B. cepacia are implicated.
Plain-English summary
Centurion Labs, LLC is recalling 4,149 bottles of Ninjacof (Chlophedianol HCL and Pyrilamine Maleate) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor. The recall is due to microbial contamination, specifically the potential presence of B. cepacia. The affected product is identified by Lot 200N1601 with an expiration date of 11/2018 and NDC 23359-032-16.
The product was distributed nationwide. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and return it to the pharmacy or point of purchase for a refund. The recall is being conducted by Centurion Labs, LLC, the manufacturer of the product.
The recalled product
- Product
- NINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE)
- Brand
- NINJACOF
- Manufacturer
- Centurion Labs, LLC
- Category
- Drug — OTC Cough and Cold
- Affected units
- 4,149
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: 200N1601 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 →Related recalls
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