Rugby Diocto Liquid recalled over sterility concerns
- Recall date
- August 2, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- The Harvard Drug Group recalls Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:…
- Recall number
- D-1119-2017
- FDA classification
- Class II
- Brand / firm
- The Harvard Drug Group
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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