Drug product
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.
D-1524-2016
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 74874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,656 bottles
- Official record key
drug-enforcement:D-1524-2016
Official wording
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot #: 22941505, Exp 10/17; 229416601, Exp 01/18; 22941602, Exp 03/18
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations