The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0225-2018·Announced 2018-01-24

Rugby Diocto Syrup Recalled for Microbial Contamination

Pharmatech LLC is recalling Rugby Diocto Syrup due to microbial contamination, including the presence of 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 agency classification is FDA Class II. The rubric assigns a score of 4 (Severe) to FDA Class II recalls, particularly when involving significant contamination risks like B. cepacia.

Plain-English summary

Pharmatech LLC is recalling Rugby Diocto Syrup, a stool softener laxative containing docusate sodium 60 mg/15 mL. The product is distributed by Rugby Laboratories and is packaged in one-pint (473 mL) plastic bottles.

The recall was initiated due to microbial contamination of the non-sterile product. Specifically, the source text identifies the presence of yeast and potential contamination with B. cepacia.

The recall applies to all lots of the product remaining within their expiration dates. The distribution pattern is listed as Michigan (MI). Consumers should stop using the product and follow instructions from the recalling firm or healthcare provider.

The recalled product

Product
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, 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 →

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