D-0225-2018 Class II Terminated
FDA drug recall D-0225-2018 was initiated by Pharmatech LLC on August 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 January 4, 2023). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- August 16, 2017
- Termination Date
- January 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, 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.