D-0227-2018 Class II Terminated
FDA drug recall D-0227-2018 was initiated by Pharmatech LLC on Aug 16, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination The recall status is terminated (terminated Jan 4, 2023).
Recall details
- Product Type
- Drugs
- Report Date
- Jan 24, 2018
- Initiation Date
- Aug 16, 2017
- Termination Date
- Jan 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
Reason for recall
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Distribution pattern
MI
Code information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0227-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026