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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 – February 13, 2016 – 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).

 

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Contact:

Pfizer Canada Media Line

1-866-9PFIZER (1-866-973-4937)

[email protected]

 

 

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