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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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