CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative recalled
Pharmatech is recalling Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative, distributed in Michigan. The recall was initiated on 16 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0225-2018
- FDA event ID
- 77960
- Recalling firm
- Pharmatech, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Aug 2017
- FDA classified
- 17 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 16 Aug 2017 | Recall initiated by company | |
| 17 Jan 2018 | Classified by FDA | +154 days |
| 24 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Product as listed by the FDA
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
Where it was distributed
MI
Questions about this recall
Is Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative recalled?
Yes. Pharmatech recalled Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative on 16 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-0225-2018.
Why was it recalled?
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
MI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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