Agency classClass IIOur severity:Severe FDA (Drugs)·D-1119-2017·Announced 2017-08-30

Rugby Diocto Liquid Recalled for Microbial Contamination

The Harvard Drug Group is recalling Rugby Diocto Liquid due to microbial contamination, including yeast and potential B. cepacia.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the recall as FDA Class II and involves microbial contamination (yeast and potential B. cepacia), which aligns with the rubric criteria for Severe (Score 4) involving significant health risks or hospitalization reports, though specific hospitalizations are not explicitly detailed in the provided snippet, the classification and pathogen type warrant this level.

Plain-English summary

The Harvard Drug Group is recalling 7,308 bottles of Rugby Diocto Liquid, Docusate Sodium 50 mg/5 mL, Stool Softener Laxative. The product is distributed in one-pint (473 mL) plastic bottles under NDC 0536-0590-85. The recall is limited to Item# 370010, Lot 20351701.

The recall was initiated because of microbial contamination, specifically the presence of yeast and potential B. cepacia contamination. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide in the USA. Consumers should check their medication for the specific lot number and stop using the product if it matches the recalled lot. They should contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product: 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
Manufacturer: The Harvard Drug Group
Category: Drug — Laxative
Hazard: microbial-contamination
b-cepacia
Affected units: 7,308

Is your product affected?

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

Lot numbers (2)

Item# 370010
Lot: 20351701

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by The Harvard Drug Group under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · The Harvard Drug Group

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Same hazard · microbial contamination