D-1524-2016 Class II Terminated
FDA drug recall D-1524-2016 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: 19,656 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
- 19,656 bottles
Product Description
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
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 #: 22941505, Exp 10/17; 229416601, Exp 01/18; 22941602, Exp 03/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1524-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026