Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plast...
FDA Drug Recall #D-1120-2017 — Class II — August 2, 2017
Recall Summary
| Recall Number | D-1120-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 2, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Harvard Drug Group |
| Location | Livonia, MI |
| Product Type | Drugs |
| Quantity | 7,272 bottles |
Product Description
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
Reason for Recall
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Item# 370282, Lot: 22941701
Other Recalls from The Harvard Drug Group
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0878-2023 | Class II | Tramadol Hydrochloride Tablets, USP 50 mg, Unit... | Jun 16, 2023 |
| D-0570-2023 | Class III | Gabapentin Tablets, USP 600 mg, packaged in Car... | Apr 24, 2023 |
| D-0432-2023 | Class II | Carbidopa and Levodopa Tablets, USP 25 mg/100 m... | Feb 23, 2023 |
| D-0649-2022 | Class II | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 10... | Feb 28, 2022 |
| D-0653-2022 | Class II | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablet... | Feb 24, 2022 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.