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Advisory - Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Health Canada
Posted on: 07 Dec 18
Advisory - Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Canada NewsWire

OTTAWA, Dec. 7, 2018

OTTAWA, Dec. 7, 2018 /CNW/ -

Issue

Laboratoire Riva Inc. and Laboratoires Trianon Inc. are voluntarily recalling five over-the-counter strawberry-flavoured acetaminophen oral drops for infants. The products are labeled as Biomedic, Option+, Personnelle, Selection, or Laboratoires Trianon Inc. The products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children's acetaminophen syrups for the same issue.

A defective cap could allow a child to accidentally ingest the product, which could pose a significant health concern. Accidental ingestion can result in acetaminophen overdose and serious health consequences, including liver damage. Early signs of overdose include nausea, vomiting, lethargy and sweating. Liver damage may result in liver failure or, in the most severe cases, death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.

This issue is related to product packaging and not the safety or effectiveness of the drug in the bottles. The products were distributed at major pharmacies across Canada.

Who is affected

  • Consumers who have bought the affected products listed in the table below

Affected products

 

Description

Company

DIN

Lot

Expiry

Units

Distributed

Biomedic

Acetaminophen

(80 mg/mL) infant oral drops, strawberry flavour 

 

24 mL bottle

Laboratoire Riva Inc.

02226898

C0217-3

20-FE

2,016

C0217-4

20-FE

1,056

C0217-8

20-FE

2,016

C0735-5

20-JL

4,224

C0735-7

20-JL

1,728

F1213

18-DE

4,128

F1213-1

18-DE

1,056

Option+

Acetaminophen infant oral drops USP

(80 mg/mL), strawberry flavour 

 

24 mL bottle

Laboratoire Riva Inc.

02226898

C0217-2

20-FE

2,016

C0217-5

20-FE

1,056

C0217-7

20-FE

2,016

C0217-A

20-FE

3,072

C0217-B

20-FE

1,248

F1213

18-DE

6,624

Personnelle

Acetaminophen infant oral drops USP

(80 mg/mL), strawberry flavour 

 

24 mL bottle

Laboratoire Riva Inc.

02226898

C0735-1

20-JL

2,598

C0735-4

20-JL

2,592

Selection

Acetaminophen infant oral drops USP

(80 mg/mL), strawberry flavour 

 

24 mL bottle

Laboratoire Riva Inc.

02226898

C0735-2

20-JL

2,397

Laboratoires Trianon Inc. Acetaminophen Oral solution USP

(80 mg/mL) children's syrup, strawberry flavour

 

24 mL bottle

Laboratoires Trianon Inc.

01905864

C0217-1

20-FE

1,056

C0217-6

20-FE

1,098

C0217-9

20-FE

995

C0735-3

20-JL

1,536

C0735-6

20-JL

2,995

F1213

18-DE

4,602

F1213-2

18-DE

880

 

What consumers should do

  • Return affected product to the place of purchase for a refund.
  • Call your local poison control centre immediately if you think your child may have taken too much acetaminophen. Consult your health care professional if your child has used these products and has health concerns.
  • Contact Urszula Wiatrowska, Pharmacovigilance Specialist at Laboratoire Riva and Laboratoires Trianon Inc., if you have questions about the recall. Email uwiatrowska@labriva.com, or call toll-free at 1-800-363-7988, extension 236.
  • Store medications out of reach and sight of children.
  • Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doing

Health Canada is monitoring the recalls and is following up with the companies to confirm that appropriate actions are taken to prevent this situation from happening again. Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

Également disponible en français

 

SOURCE Health Canada

PR Newswire
www.prnewswire.com

Last updated on: 07/12/2018

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