Diocto Liquid Stool Softener Recalled for Microbial Contamination

Plain-English summary

The Harvard Drug Group is voluntarily recalling 153,432 bottles of Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative. The product is distributed in one-pint (473 mL) bottles under NDC 0536-0590-85. The recall is being conducted because of microbial contamination, specifically positive findings of Burkholderia cepacia in non-sterile products.

The affected lots were distributed nationwide. The specific lot codes and expiration dates involved in the recall range from September 2016 to April 2018. Consumers should check their bottles for the specific lot codes and expiration dates listed in the official recall notice to determine if they are affected.

Individuals with the affected product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund. The FDA classifies this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

Manufacturer

The Harvard Drug Group

Category

Drug — Laxative

Hazard

• microbial-contamination
• burkholderia-cepacia

Affected units

153,432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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