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Recall Observatory FDA recall evidence

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

August 08, 2016

Class II

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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations