The Recall Desk
ModerateFDA (Drugs)·D-1524-2016·Announced 2016-10-05

Pharmatech Recalls Diocto Syrup Due to Potential B. cepacia Contamination

Pharmatech LLC is recalling Diocto Syrup (docusate sodium) nationwide due to a potential risk of contamination with B. cepacia bacteria.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is explicitly described as a 'precautionary measure' due to a 'potential risk' of contamination, with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharmatech LLC is recalling 19,656 bottles of Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, distributed by Rugby Laboratories. The affected product is identified by NDC 0536-1001-85 and includes lots 22941505 (Exp 10/17), 229416601 (Exp 01/18), and 22941602 (Exp 03/18). The recall is distributed nationwide.

The recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. This action is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and contact Pharmatech LLC or your healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Manufacturer
Pharmatech LLC
Affected units
19,656

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 (6)

  • Lot #: 22941505
  • Exp 10/17
  • 229416601
  • Exp 01/18
  • 22941602
  • Exp 03/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →