D-0224-2018 Class II Terminated
FDA drug recall D-0224-2018 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 Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, 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-0224-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026