Class II · Moderate risk Ongoing
Docusate Sodium 250 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Diocto Liquid
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
What was recalled
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
- Recalling firm
- The Harvard Drug Group
- NDC code
- 0536-0590-85
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0022-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Docusate recalls
See all
Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Docu Liquid
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Sankaijo BOTANICAL LAXATIVE
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk Terminated
Preferred Plus Dioctyl Liquid Stool Softener
Reason cGMP Deviations: Products may have microbial contamination.
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