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

Starting date: February 12, 2016 Posting date: February 12, 2016 Type of communication: Information Update Subcategory: Children's Products, Drugs, Affects children, pregnant or breast feeding women, Affects children, pregnant or breast feeding women Source of recall: Health Canada Issue: Product withdrawal, Important Safety Information Audience: General Public Identification number: RA-57140

Issue

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 J18259 2016-04-30 J29783 2016-06-30 J42602 2016-10-31 J45638 2016-06-30 J45639 2016-06-30 J50036 2016-11-30 J57962 2016-07-31 J64028 2016-11-30 J64555 2016-11-30 J75537 2016-09-30 J75622 2016-08-31 J75624 2016-07-31 J90515 2016-08-31 L21292 2017-01-31 L34832 2017-01-31 L60901 2017-05-31 L60915 2017-04-30 L95489 2017-07-31 L95525 2017-05-31 L95530 2017-07-31 Children's Advil Cold

DIN 02248435 L98621 2017-08-31 R17653 2016-09-30 R23674 2017-03-31 Children's Advil Fever from Colds or Flu

DIN 02328437 J42100 2017-11-30 J45606 2017-06-30 L44485 2018-02-28 L79027 2018-08-31 Children's Advil

DIN 02232297 H13899 2016-03-31 H98207 2016-02-29 H98635 2017-03-31 J18208 2017-03-31 J18209 2017-03-31 J18210 2017-03-31 J18211 2016-04-30 J18219 2016-03-31 J18249 2016-04-30 J18449 2016-05-31 J18451 2016-05-31 J29738 2016-05-31 J29739 2016-05-31 J29740 2016-05-31 J29750 2016-05-31 J29771 2016-05-31 J29789 2016-05-31 J29815 2017-04-30 J29868 2016-05-31 J29877 2016-05-31 J29878 2017-06-30 J45608 2016-07-31 J45613 2016-06-30 J45622 2016-06-30 J49017 2016-11-30 J49018 2016-12-31 J49035 2016-12-31 J49054 2016-12-31 J49055 2016-12-31 J49056 2016-12-31 J49591 2016-12-31 J49946 2017-11-30 J57911 2016-08-31 J57912 2016-08-31 J57913 2016-08-31 J57914 2016-09-30 J57915 2016-09-30 J57916 2016-09-30 J57920 2016-09-30 J57924 2016-09-30 J57937 2016-09-30 J57938 2017-08-31 J57952 2017-08-31 J63997 2016-10-31 J64025 2016-10-31 J64174 2016-10-31 J64271 2017-11-30 J75500 2016-08-31 J75521 2016-09-30 J75587 2016-09-30 J75606 2016-12-31 J80823 2016-08-31 J80824 2016-09-30 J90489 2016-10-31 J90490 2016-10-31 J90491 2016-10-31 J90492 2016-10-31 L21296 2017-12-31 L21304 2018-01-31 L21333 2016-12-31 L34743 2017-01-31 L34744 2017-01-31 L36035 2017-06-30 L44489 2017-02-28 L44503 2017-01-31 L60902 2017-04-30 L60913 2017-04-30 L60914 2017-05-31 L60919 2018-04-30 L79079 2017-08-31 L79082 2017-08-31 L79109 2017-08-31 L79286 2017-08-31 L79542 2017-08-31 L79547 2017-08-31 L90679 2017-05-31 L90680 2017-06-30 L90681 2017-05-31 L90682 2017-05-31 L92069 2017-05-31 L93754 2017-08-31 L94962 2017-06-30 L94963 2017-06-30 L94964 2017-06-30 L94966 2017-06-30 L94975 2017-07-31 L94976 2017-07-31 L94977 2017-07-31 L94978 2017-05-31 L95491 2018-06-30 L95493 2018-06-30 L95500 2017-06-30 L95514 2018-07-31 M01103 2017-08-31 M06649 2017-08-31 M06650 2017-08-31 M11856 2017-08-31 Advil Pediatric Drops Fever from Colds or Flu

DIN 02328445 J57902 2016-07-31 L60899 2017-05-31

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