Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL)…
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of…
Reason Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of…
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