D-1522-2016 Class II Terminated
FDA drug recall D-1522-2016 was initiated by Pharmatech LLC on Aug 8, 2016 and is designated Class II. Reason for recall: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. The recall status is terminated (terminated Sep 23, 2024). Affected quantity: 1,332 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 5, 2016
- Initiation Date
- Aug 8, 2016
- Termination Date
- Sep 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,332 bottles
Product Description
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/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 23359-033-16.
Reason for Recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Distribution Pattern
Nationwide
Code Information
Lot #: 25321601, Exp 04/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1522-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026