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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 |
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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