Recalls / Class II
Class IID-0224-2018
Product
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Recalling firm
- Firm
- Pharmatech LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4131 SW 47th Ave Ste 1403, N/A, Davie, Florida 33314-4036
Distribution
- Quantity
- Unknown
- Distribution pattern
- MI
Timeline
- Recall initiated
- 2017-08-16
- FDA classified
- 2018-01-17
- Posted by FDA
- 2018-01-24
- Terminated
- 2023-01-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0224-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.