FDAAugust 8, 2016drug
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
What to do
FDA enforcement status: Terminated
Brands named
pharmatech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARugby Tri-Vitamin Liquid 1 2/3 fl. oz. (50 mL) UPC 00536-8501-802017-08-16
- FDAMajor Certa-Vite Liquid 236 mL UPC 00904-5023-092017-08-16
- FDARugby FER Iron Liquid 50 mL UPC 00536-0710-802017-08-16
- FDAMajor D-Vita Drops 50 mL UPC 00904-6273-502017-08-16
- FDAMajor Poly-Vita Drops w/ Iron 50 mL UPC 00904-5100-502017-08-16
- FDARugby D3 Vitamin liquid 400 IU/1 mL dose 1 2/3 fl. oz. (50 mL) UPC 00536-8400-802017-08-16
- FDARugby Ferrous Sulfate Elixir 473 mL UPC: 00536-0650-852017-08-16
- FDARugby 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, FL2017-08-16
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