Drug & medication recalls Moderate risk

Rugby Diocto Syrup 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 Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:…
Recall number
D-1120-2017
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 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

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