CLASS II Drug recall · Reported 30 Aug 2017 · FDA Enforcement Report
Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative recalled
The Harvard Drug Group is recalling Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative, distributed nationwide in the US. The recall was initiated on 2 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-1120-2017
- FDA event ID
- 77869
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2017
- FDA classified
- 24 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Mold
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 2 Aug 2017 | Recall initiated by company | |
| 24 Aug 2017 | Classified by FDA | +22 days |
| 30 Aug 2017 | Published in enforcement report | +6 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 Products; 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, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Which lots are affected?
Item# 370282, Lot: 22941701
Where was it sold?
Nationwide in the USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 77869| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rugby Diocto Liquid, Docusate Sodium 50 mg/, Stool Softener Laxative recalled | The Harvard Drug Group | Mold | Nationwide | |
| CLASS II | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg recalled | The Harvard Drug Group | Mold | Nationwide | |
| CLASS II | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg recalled | The Harvard Drug Group | Mold | Nationwide | |
| CLASS II | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg recalled | The Harvard Drug Group | Mold | Nationwide |
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Rugby Diocto recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rugby Diocto Syrup, Docusate Sodium 60 mg/, Stool Softener Laxative recalled | Pharmatech | Mold | MI |