Bayer expands recall of RestoraLAX, sold nationwide, due to potential choking hazard

Starting date:

July 8, 2017

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-63908

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

Further to a recent recall of RestoraLAX 45+10, Health Canada is advising Canadians that Bayer Inc. is expanding its voluntary recall to include specific lots of RestoraLAX 30+7 Bonus Packs sold at various retailers across Canada due to a potential choking hazard.

Specific lots of RestoraLAX 30+7 Bonus Packs may contain deposits such as clumps or lumps.‎ The presence of these deposits may pose a choking hazard.

RestoraLAX is used to relieve occasional constipation and irregularity.

Products affected

The following lots of RestoraLAX 30+7 Bonus Packs (DIN 02318164):

• 5M03PU
• 5M09PU
• 6G02PU
• 6G03PU
• 6E25PU

This product is sold as a combination pack: 1 bottle of 30 doses of RestoraLAX powder, shrink wrapped together with 1 bottle of 7 doses of RestoraLAX powder.

What you should do

• Stop using this product. Seek immediate medical attention if you experience difficulty swallowing or breathing after taking this product.
• Consult with your health care professional if you have used it and have health concerns.
• Contact Bayer at 1-800-265-7382 or visit bayer.ca if you have questions about this recall.
• Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

Consumers who have bought or used the affected RestoraLAX 30+7 Bonus Packs ‎sold nationwide.

Background

Bayer Inc. has advised that the issue is associated with a packaging process specific to the RestoraLAX® 45+10 Value Packs and the RestoraLAX 30+7 Bonus Packs, and that no other RestoraLAX packaging formats are impacted or being recalled at this time.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866-225-0709

What Health Canada is doing

Health Canada is monitoring the company's recall. If new safety information is identified, Health Canada will take appropriate action and inform Canadians as necessary.

Images

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