Information Update - Pfizer Consumer Healthcare recalling 126 lots of Advil liquid products for infants and children

OTTAWA, Feb. 12, 2016 /CNW/ - Health Canada is informing Canadians that Pfizer Consumer Healthcare has initiated a voluntary recall of 126 lots of Advil liquid products for infants and children because of a potential risk of inconsistences in dosing of the product.

"Clumps" of Ibuprofen may form in the bottle and lead to higher or lower doses that are given to infants and children if it is not shaken well before each use.

Lower doses may not be adequate in reducing the fever, leading to other health issues which could include, in rare instances, convulsions. Although unlikely, higher doses may lead to vomiting, drowsiness, dizziness, 'ringing in the ears' and decreased breathing rates.  

The likelihood of these potentially severe adverse consequences is remote as long as the product has always been shaken well before each use as per label instructions.

As a precaution, Health Canada is recommending that consumers stop using these products and return them to a pharmacy.

Health Canada is advising parents who have given these products to their children and have concerns to consult with their health care practitioner.

Health Canada is monitoring Pfizer's recall and will inform Canadians if new safety information arises.

Product	Lots	Expiry date
Advil Pediatric Drops DIN 02242522	J75537 L60915 J29783 L21292 L95489 J45638 J64555 L95525 J18259 J42602 J45639 J57962 J64028 J75622 L34832 L60901 L95530 J50036 J75624 J90515	2016-09-30 2017-04-30 2016-06-30 2017-01-31 2017-07-31 2016-06-30 2016-11-30 2017-05-31 2016-04-30 2016-10-31 2016-06-30 2016-07-31 2016-11-30 2016-08-31 2017-01-31 2017-05-31 2017-07-31 2016-11-30 2016-07-31 2016-08-31
Children's Advil Cold DIN 02248435	R17653 R23674 L98621	2016-09-30 2017-03-31 2017-08-31
Children's Advil Fever from Colds or Flu DIN 02328437	J42100 J45606 L44485 L79027	2017-11-30 2017-06-30 2018-02-28 2018-08-31
Children's Advil DIN 02232297	J18208 J18209 J18210 J29738 J29739 J29740 J49017 J49018 J49035 J49054 J49055 J57911 J57912 J57913 J57914 J57915 J57916 J90489 J90490 J90491 L34743 L44489 L60902 L79079 L79082 L79109 L90679 L90680 L90681 L94962 L94963 L94964 J18211 J45608 J49056 J75500 J90492 L34744 L90682 L94966 H98207 J45613 J57920 L79286 L94976 H13899 J29750 J57924 L44503 L94977 J18219 J29771 J45622 J49591 J63997 J75521 L60913 L60914 L79542 L79547 L94975 J18449 J80823 L94978 J18451 J80824 L92069 M01103 M06649 M06650 J29789 J57937 J64025 J75587 L21296 L95491 J29815 J57938 J64174 L21304 L95493 J18249 J29868 J75606 L21333 L95500 M11856 H98635 J29877 J29878 J49946 J57952 J64271 L60919 L95514 L36035 L93754	2016-03-31 2016-03-31 2016-03-31 2016-05-31 2016-05-31 2016-05-31 2016-11-30 2016-12-31 2016-12-31 2016-12-31 2016-12-31 2016-08-31 2016-08-31 2016-08-31 2016-09-30 2016-09-30 2016-09-30 2016-10-31 2016-10-31 2016-10-31 2017-01-31 2017-02-28 2017-04-30 2017-08-31 2017-08-31 2017-08-31 2017-05-31 2017-06-30 2017-05-31 2017-06-30 2017-06-30 2017-06-30 2016-04-30 2016-07-31 2016-12-31 2016-08-31 2016-10-31 2017-01-31 2017-05-31 2017-06-30 2016-02-29 2016-06-30 2016-09-30 2017-08-31 2017-07-31 2016-03-31 2016-05-31 2016-06-30 2017-01-31 2017-07-31 2016-03-31 2016-05-31 2016-07-31 2016-12-31 2016-10-31 2016-09-30 2017-04-30 2017-05-31 2017-08-31 2017-08-31 2017-07-31 2016-05-31 2016-08-31 2017-05-31 2016-05-31 2016-09-30 2017-05-31 2017-08-31 2017-08-31 2017-08-31 2017-05-31 2017-06-30 2017-10-31 2017-09-30 2017-12-31 2018-06-30 2017-04-30 2017-08-31 2017-10-31 2018-01-31 2018-06-30 2016-04-30 2016-05-31 2016-12-31 2016-12-31 2017-06-30 2017-08-31 2017-03-31 2017-05-31 2017-06-30 2017-11-30 2017-08-31 2017-11-30 2018-04-30 2018-07-31 2017-06-30 2017-08-31
Advil Pediatric Drops Fever from Colds or Flu DIN 02328445	J57902 L60899	2016-07-31 2017-05-31

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709