Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Rugby Diocto Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
Affected NDC
0536-1001-85
Compare with the code on your package — it is the most precise check available.
Drug: Docusate
- Recalling firm
- The Harvard Drug Group
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1120-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Docusate recalls
See all
Class II · Moderate risk
OneLAX Docusate Sodium Liquid
CGMP Deviations
Class II · Moderate risk
Docu Liquid
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Other recalls by The Harvard Drug Group
All 2017 recalls
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Class II · Moderate risk
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
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