The Recall Desk
SevereFDA (Drugs)·D-0224-2018·Announced 2018-01-24

Rugby Diocto Liquid Recalled for Microbial Contamination

PharmaTech LLC 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 agency classification is FDA Class II, and the presence of B. cepacia, a high-risk pathogen, in a non-sterile product warrants a Severe rating per the rubric for significant injury/property-damage reports or high-risk pathogens.

Plain-English summary

PharmaTech LLC is recalling Rugby Diocto Liquid, a docusate sodium stool softener laxative, due to microbial contamination. The product is distributed by Rugby Laboratories and is available in one-pint (473 mL) plastic bottles.

The recall was initiated because of the presence of yeast and potential B. cepacia contamination in the non-sterile product. The source text does not specify the number of units affected or the specific distribution locations beyond the manufacturer's location in Davie, FL, and distributor in Livonia, MI.

Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The source text does not provide specific contact information or a return policy.

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, Manufactured by PharmaTech LLC, Davie, FL
Manufacturer
Pharmatech LLC

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 (1)

  • All lots remaining within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Pharmatech LLC 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 4 products in this recall →