Pfizer voluntarily recalls certain lots of Advil® Pediatric Drops and Children's Advil® Oral Suspension products due to potential risk of inconsistencies in dosing

MISSISSAUGA, ON, Feb. 13, 2016 /CNW/ - Pfizer Canada Inc. has voluntarily recalled certain Advil® Pediatric Drops (Ibuprofen 200 mg/5 mL USP) and Children's Advil® (Ibuprofen 100 mg/5 mL USP) Ibuprofen Oral Suspension products. The lots are being recalled as a precautionary measure because of a potential risk of inconsistencies 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.

No serious adverse events have been reported. However, as a precaution Pfizer is asking consumers to stop using these products and return the recalled product to their pharmacy for safe disposal. Parents who have given these products to their children and have concerns should consult with their health care practitioner.

This recall has been classified as a Type II, a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

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 potential severe adverse consequences is remote as long as the product has always been shaken well before each use as per label instructions.

The issue was identified during routine stability testing, in which products are tested to ensure that they maintain their integrity over time and as they reach their expiration dates. The issue was caused by a change to an emulsifying ingredient (xanthan gum) from one of Pfizer's suppliers, which allowed ibuprofen in the liquid suspension to separate over time in the affected products.

"Our top priority is delivering safe and top quality products that Canadians can trust," said David Lessard, Director, Quality & Compliance, Pfizer Global Supply. "As soon as the product issue was identified, we took action to investigate any potential safety issues associated with the product. We also worked to track the cause, and replaced the source of one ingredient that was found to be the cause of the issue. The situation is now fully resolved, and parents can be confident that all Advil® Pediatric Drops and Children's Advil® Ibuprofen Oral Suspension products in production meet Pfizer's stringent quality requirements."

The voluntary recall involves wholesalers, retailers, physicians' offices and consumers and is being conducted in collaboration with Health Canada. No other products have been affected or are involved in this voluntary recall.

To find out whether a product is affected by the recall, Canadian consumers can check the lot number on the side of the bottle and see below to view a list of all impacted lots. If affected, consumers are asked to bring it back to the pharmacy where it can be safely disposed and call Pfizer at 1-888-275-9938 to receive a full refund.

About Pfizer Canada Inc. – www.pfizer.ca 
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines, infusion systems and vaccines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/Pfizer.Canada). 

List of affected products

DIN	Product Description	Lot	expiry date
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J18208	3/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J18209	3/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J18210	3/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J29738	5/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J29739	5/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J29740	5/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J49017	11/30/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J49018	12/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J49035	12/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J49054	12/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J49055	12/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57911	8/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57912	8/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57913	8/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57914	9/30/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57915	9/30/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J57916	9/30/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J90489	10/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J90490	10/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	J90491	10/31/2016
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L34743	1/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L44489	2/28/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L60902	4/30/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L79079	8/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L79082	8/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L79109	8/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L90679	5/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L90680	6/30/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L90681	5/31/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L94962	6/30/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L94963	6/30/2017
02232297	ADVIL CHILDREN SUSP GRAPE DF 230 ML CA	L94964	6/30/2017
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	J18211	4/30/2016
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	J45608	7/31/2016
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	J49056	12/31/2016
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	J75500	8/31/2016
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	J90492	10/31/2016
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	L34744	1/31/2017
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	L90682	5/31/2017
02232297	ADVIL CHILDREN SUSP BLUE RASP 230 ML CA	L94966	6/30/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 100 ML CA	H98207	2/29/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 100 ML CA	J45613	6/30/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 100 ML CA	J57920	9/30/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 100 ML CA	L79286	8/31/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 100 ML CA	L94976	7/31/2017
02232297	ADVIL CHILD SUSP BERRY DF 100 ML CA	H13899	3/31/2016
02232297	ADVIL CHILD SUSP BERRY DF 100 ML CA	J29750	5/31/2016
02232297	ADVIL CHILD SUSP BERRY DF 100 ML CA	J57924	6/30/2016
02232297	ADVIL CHILD SUSP BERRY DF 100 ML CA	L44503	1/31/2017
02232297	ADVIL CHILD SUSP BERRY DF 100 ML CA	L94977	7/31/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J18219	3/31/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J29771	5/31/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J45622	7/31/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J49591	12/31/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J63997	10/31/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	J75521	9/30/2016
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	L60913	4/30/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	L60914	5/31/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	L79542	8/31/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	L79547	8/31/2017
02232297	ADVIL CHILD SUSP BUBBLE GUM DF 230ML CA	L94975	7/31/2017
02232297	ADVIL CHILD SUSP GRA DF 1X120ML BONUS CA	J18449	5/31/2016
02232297	ADVIL CHILD SUSP GRA DF 1X120ML BONUS CA	J80823	8/31/2016
02232297	ADVIL CHILD SUSP GRA DF 1X120ML BONUS CA	L94978	5/31/2017
02232297	ADVIL CHILD SUSP BUB DF 1X120ML BONUS CA	J18451	5/31/2016
02232297	ADVIL CHILD SUSP BUB DF 1X120ML BONUS CA	J80824	9/30/2016
02232297	ADVIL CHILD SUSP BUB DF 1X120ML BONUS CA	L92069	5/31/2017
02232297	ADVIL SUSP GRAPE DF 260ML CA	M01103	8/31/2017
02232297	ADVIL SUSP GRAPE DF 260ML CA	M06649	8/31/2017
02232297	ADVIL SUSP GRAPE DF 260ML CA	M06650	8/31/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	J29789	5/31/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	J57937	6/30/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	J64025	10/31/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	J75587	9/30/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	L21296	12/31/2017
02232297	CHILDRENS ADVIL GRAPE 100ML	L95491	6/30/2018
02232297	CHILDRENS ADVIL FRUIT 100ML	J29815	4/30/2017
02232297	CHILDRENS ADVIL FRUIT 100ML	J57938	8/31/2017
02232297	CHILDRENS ADVIL FRUIT 100ML	J64174	10/31/2017
02232297	CHILDRENS ADVIL FRUIT 100ML	L21304	1/31/2018
02232297	CHILDRENS ADVIL FRUIT 100ML	L95493	6/30/2018
02232297	CH ADVIL SUSP BLUE RASP 100ML	J18249	4/30/2016
02232297	CH ADVIL SUSP BLUE RASP 100ML	J29868	5/31/2016
02232297	CH ADVIL SUSP BLUE RASP 100ML	J75606	12/31/2016
02232297	CH ADVIL SUSP BLUE RASP 100ML	L21333	12/31/2016
02232297	CH ADVIL SUSP BLUE RASP 100ML	L95500	6/30/2017
02232297	CH ADVIL SUSP BLUE RASP 100ML	M11856	8/31/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	H98635	3/31/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	J29877	5/31/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	J29878	6/30/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	J49946	11/30/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	J57952	8/31/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	J64271	11/30/2017
02232297	CHILDRENS ADVIL SUSP DF 100ML	L60919	4/30/2018
02232297	CHILDRENS ADVIL SUSP DF 100ML	L95514	7/31/2018
02232297	CHILDREN'S ADVIL DYE FREE 25ML	L36035	6/30/2017
02232297	CHILDREN'S ADVIL DYE FREE 25ML	L93754	8/31/2017
02242522	ADVIL PED DROPS GRAPE 24ML	J75537	9/30/2016
02242522	ADVIL PED DROPS GRAPE 24ML	L60915	4/30/2017
02242522	ADVIL PED DROPS FRUIT 24ML	J29783	6/30/2016
02242522	ADVIL PED DROPS FRUIT 24ML	L21292	1/31/2017
02242522	ADVIL PED DROPS FRUIT 24ML	L95489	7/31/2017
02242522	ADVIL PED DROPS GRAPE DF 15 ML	J45638	6/30/2016
02242522	ADVIL PED DROPS GRAPE DF 15 ML	J64555	11/30/2016
02242522	ADVIL PED DROPS GRAPE DF 15 ML	L95525	5/31/2017
02242522	ADVIL PED DROPS DF GRAPE 24ML	J18259	4/30/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	J42602	10/31/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	J45639	6/30/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	J57962	7/31/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	J64028	11/30/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	J75622	8/31/2016
02242522	ADVIL PED DROPS DF GRAPE 24ML	L34832	1/31/2017
02242522	ADVIL PED DROPS DF GRAPE 24ML	L60901	5/31/2017
02242522	ADVIL PED DROPS DF GRAPE 24ML	L95530	7/31/2017
02242522	ADVIL PED DROPS DYE FREE SMPLl	J50036	11/30/2016
02242522	ADVIL PED DROPS DYE FREE SMPLl	J75624	7/31/2016
02242522	ADVIL PED DROPS DYE FREE SMPLl	J90515	8/31/2016
02248435	ADVIL CHILD COLD SUSP GRAPE 120 ML CA	L98621	8/31/2017
02328437	ADVIL CHILD SUSP FEVER C&F GRDF 100ML CA	J42100	11/30/2017
02328437	ADVIL CHILD SUSP FEVER C&F GRDF 100ML CA	J45606	6/30/2017
02328437	ADVIL CHILD SUSP FEVER C&F GRDF 100ML CA	L44485	2/28/2018
02328437	ADVIL CHILD SUSP FEVER C&F GRDF 100ML CA	L79027	8/31/2018
02328445	ADVIL PED DROPS FEVER C&F GR DF 24ML CA	J57902	7/31/2016
02328445	ADVIL PED DROPS FEVER C&F GR DF 24ML CA	L60899	5/31/2017
02248435	CHILDRENS ADVIL COLD SUSP GRAPE 120ML	R17653	9/30/2016
02248435	CHILDRENS ADVIL COLD SUSP GRAPE 120ML	R23674	3/31/2017

SOURCE Pfizer Canada Inc.

Pfizer Canada Media Line, 1-866-9PFIZER (1-866-973-4937), [email protected]