The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1120-2017·Announced 2017-08-30

Rugby Diocto Syrup Recalled for Microbial Contamination

The Harvard Drug Group is recalling Rugby Diocto Syrup 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 recall is classified as FDA Class II and involves potential B. cepacia contamination, which is a high-risk pathogen associated with severe infections, meeting the criteria for a Severe rating.

Plain-English summary

The Harvard Drug Group is recalling 7,272 bottles of Rugby Diocto Syrup, a stool softener laxative. The product is distributed in one-pint (473 mL) plastic bottles and is identified by Item# 370282 and Lot 22941701.

The recall was initiated because of microbial contamination, specifically the presence of yeast and potential B. cepacia contamination in the non-sterile product. The affected units were distributed nationwide in the USA.

Consumers who have this product should stop using it and contact The Harvard Drug Group for further instructions or a refund.

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, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
Manufacturer
The Harvard Drug Group
Category
Drug — Laxative
Hazard
Affected units
7,272

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# 370282
  • Lot: 22941701

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 →

Related recalls

Same manufacturer · The Harvard Drug Group

See all →

Same hazard · microbial contamination

See all →

Similar recalls