FDA-Drug2018-01-24Class II

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

Pharmatech LLC
Hazard

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

Sold states
MI
Affected count
Unknown
Manufactured in
4131 SW 47th Ave Ste 1403, N/A, Davie, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0225-2018

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