Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Diocto Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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
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.
Affected NDC
0536-1001-85
Compare with the code on your package — it is the most precise check available.
Drug: Docusate
- Recalling firm
- Pharmatech LLC
- NDC code
- 0536-1001-85
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1524-2016 · 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 Pharmatech LLC
All 2016 recalls
Class II · Moderate risk
Rugby Aller-chlor
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Senexon Liquid Natural Vegetable Stimulant
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Syrup
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Liquid
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
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