2014

Novartis Pharma Logistics, Inc. voluntarily recalling in Curacao select lots of certain over-the-counter products due to bottle closure defect -- Voluntary recall of certain lots of Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley's® Complete Liquids, issued to consumers, retail customers and wholesalers in Curacao

-- Consumers who may have the product(s) being recalled are asked to return the affected products and receive a full refund

-- The products being recalled were produced at a Novartis Consumer Health manufacturing facility in the United States prior to the voluntary suspension of operations in December 2011, and at a third-party manufacturing site in Canada using the same bottle and cap components

PANAMA CITY, Feb. 5, 2013 /PRNewswire/ -- Novartis Pharma Logistics, Inc. announced today that it is voluntarily recalling certain lots of Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley's® Complete Liquids. Novartis Pharma Logistics has decided to issue a voluntary recall to consumers, retail customers and wholesalers in Curacao because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. The affected bottle sizes are included at the end of this release.

Novartis Pharma Logistics has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. Novartis Consumer Health, Inc. in the United States received four adverse events for Triaminic® Syrups related to this issue.

Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley's® Complete Liquids continue to be safe and effective when used as directed on the package label.

The products being recalled were produced at a Novartis Consumer Health manufacturing facility in US prior to the voluntary suspension of operations in December 2011. In addition to production at the US manufacturing site, Buckley's Complete® was also produced until January 2013 at a third-party manufacturing site in Canada.  A consumer complaint in the US in late November 2012 triggered an internal investigation by Novartis Consumer Health that determined a voluntary recall was in the best interest of consumers.

Action to be taken by consumers
Novartis Pharma Logistics advises consumers who believe they have product included in this recall to discontinue use and return the recalled product to the store or pharmacy where it was purchased for a full refund.  Only recalled product in the original bottle will be eligible for a refund. Consumers may contact the Novartis Consumer Relationship Center at 877-769-8420 (available Monday-Saturday 8 a.m. to 6 p.m. Eastern Time) for more detailed information about the recall, including which products are impacted, and for information on how to return the affected products and receive a full refund.

Action to be taken by retailers and wholesalers
Retailers and wholesalers should stop distribution and return the affected lots using the Novartis Product Return information that is being provided to them. Retailers that receive product returns from consumers will be reimbursed by Novartis Pharma Logistics.

This recall is being conducted with the full knowledge of the Curacao Public Health Department.

Disclaimer 
The foregoing release contains forward-looking statements including express or implied discussions regarding potential future revenues from Novartis OTC products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Novartis OTC products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

Novartis Media Relations

Julie Masow

Novartis Corporation

+1 212 830 2465 (direct)

+1 862 579 8456 (mobile)

julie.masow@novartis.com

 

Pamela McKinlay

Novartis Consumer Health, Inc.

+1 973 503 7337(direct)

+1 862 221 0151(mobile)

pamela.mckinlay@novartis.com

 

e-mail: us.mediarelations@novartis.com

Milicent Brooks

Novartis Consumer Health, Inc.

+1 973 503 7483(direct)

+1 973 479 2078 (mobile)

milicent.brooks@novartis.com

 

Francisco Ericastilla

Novartis Farmaceutica, S.A. (AC)

+502 242 28438 (direct)

+502 571 09426 (mobile)

francisco.ericastilla@novartis.com

 

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Theraflu Warming Relief® Syrups


PRODUCT

Item UPC NUMBER

NDC NUMBER

Case UCC NUMBER

Size

LOT

EXPIRY DATE

Theraflu ® Warming Relief Flu and Sore Throat, 8.3 oz.

300436265081

43626508

10300436265088

8.3 oz

10108935

03/31/2013

10096570

05/31/2013

10121298

05/31/2013

10123035

05/31/2013

10106483

06/30/2013

10126716

07/31/2013

Theraflu® Daytime Warming Relief Severe Cold and Cough, 8.3 oz.

300430461083

43046108

10300430461080

8.3 oz

10096571

04/30/2013

10117845

04/30/2013

10102070

06/30/2013

10118134

06/30/2013

10118135

08/31/2013

10126586

08/31/2013

10126729

10/31/2013

Theraflu® Daytime/Nighttime Severe Cold & Cough Value Pack

300436412164

67641216

10300436412161


10120065

03/01/2013

10116591A

03/13/2013

10116591

03/31/2013

10116593

03/31/2013

10106487

05/31/2013

10108285

05/31/2013

10116594

06/30/2013

10116597

06/30/2013

10116598

06/30/2013

10116600

06/30/2013

10116601

08/31/2013

10116602

08/31/2013

Theraflu® Nighttime Warming Relief Severe Cold and Cough, 8.3 oz.

300430460086

43046008

10300430460083

8.3 oz

10104954

04/30/2013

10104955

05/31/2013

10107018

05/31/2013

10118113

05/31/2013

10123039

05/31/2013

10104956

07/31/2013

10126861

08/31/2013

Theraflu® Warming Relief Cold and Chest Congestion, 8.3 oz.

300436296085

43629608

10300436296082

8.3 oz

10106482

01/31/2013

10102071

07/31/2013

10113497

07/31/2013

10122891

08/31/2013

10123274

08/31/2013

10126440

09/30/2013

10128457

11/30/2013

Theraflu® Warming Relief Sinus and Cold, 8.3 oz.

300436407085

67640708

10300436407082

8.3 oz

10095358

04/30/2013

10104966

07/31/2013

Triaminic® Syrups

PRODUCT

Item UPC NUMBER

NDC NUMBER

Case UCC NUMBER

Size

LOT

EXPIRY DATE

Triaminic® Cold and Allergy, 4 oz.

300436346049

67634604

10300436346046

4 oz

10092519

01/31/2013

10096507

02/28/2013

10092518

04/30/2013

10102344

05/31/2013

10102052

06/30/2013

10098505

07/31/2013

10106511

11/30/2013

10099191

12/31/2013

10122929

02/28/2014

10125956

05/31/2014

Triaminic® Cough and Sore Throat, 4 oz.

300436348043

67634804

10300436348040

4 oz

10104678

02/28/2013

10107025

02/28/2013

10107026

05/31/2013

10117681

06/30/2013

10118052

08/31/2013

10126850

09/30/2013

Triaminic® Day Time Cold and Cough, 4 oz.

300436345042

67634504

10300436345049

4 oz

10092520

01/31/2013

10095545

01/31/2013

10117453

02/28/2013

10097308

03/31/2013

10095904

04/30/2013

10099699

05/31/2013

10102053

06/30/2013

10103616

07/31/2013

10107024

08/31/2013

10103617

09/30/2013

10114266

10/31/2013

10116660

11/30/2013

10116869

12/31/2013

10116870

02/28/2014

10126445

03/31/2014

Triaminic® Daytime/Nighttime Cold & Cough Club Pack

300436417121

N/A

10300436417135


10095327

01/31/2013

10095907

01/31/2013

10097748

01/31/2013

10095298

04/30/2013

10117817

12/31/2013

10117818

03/31/2014

10117819

03/31/2014

Triaminic® Daytime/Nighttime Cold & Cough Combo Pack

300436216083

67621608

10300436216080


10095906

01/31/2013

10099216

02/28/2013

10100792

04/30/2013

10100793

04/30/2013

10101494

05/31/2013

10101495

05/31/2013

10106846

05/31/2013

10104675

06/30/2013

10106086

06/30/2013

10106088

07/31/2013

10106284

07/31/2013

10106848

08/31/2013

10110968

08/31/2013

10113146

09/30/2013

10113147

11/30/2013

10115037

11/30/2013

10116592

12/31/2013

Triaminic® Syrups (Cont.)


PRODUCT

Item UPC NUMBER

NDC NUMBER

Case UCC NUMBER

Size

LOT

EXPIRY DATE

Triaminic® Daytime/Nighttime Cold & Cough Combo Pack (Cont.)

300436216083

67621608

10300436216080


10116595

12/31/2013

10116596

12/31/2013

10116599

03/31/2014

10123383

03/31/2014

10123388

03/31/2014

Triaminic® Dye‐free Long Acting Cough, 4 oz.

300436350046

67635004

10300436350043

4 oz

10081942

04/30/2013

10082283

04/30/2013

10081940

06/30/2013

10097082

07/31/2013

10082927

09/30/2013

10095893

10/31/2013

10095894

10/31/2013

10102049

11/30/2013

10102048

12/31/2013

10106251

12/31/2013

10102051

01/31/2014

10107021

02/28/2014

10107022

05/31/2014

10118430

07/31/2014

10121529

08/31/2014

10129170

11/30/2014

Triaminic® Fever Reducer Pain Reliever Bubblegum, 4 oz.

300436432049

67643204

10300436432046

4 oz

10093941

01/31/2013

10102270

02/28/2013

10112423

03/31/2013

10106334

05/31/2013

10116891

08/31/2013

Triaminic® Fever Reducer Pain Reliever Grape, 4 oz.

300436431042

67643104

10300436431049

4 oz

10092719

01/31/2013

10108530

02/28/2013

10112422

03/31/2013

10106335

05/31/2013

10093939

08/31/2013

10126470

10/31/2013

10127629

11/30/2013

10130550

11/30/2013

Triaminic® Fever Reducer Pain Reliever Infant Bubblegum, 2 oz.

300676441597

67644159

10300676441594

2 oz

10115515

05/31/2013

10115516

05/31/2013

10115520

05/31/2013

10115521

05/31/2013

10119567

09/30/2013

10128589

11/30/2013

Triaminic® Fever Reducer Pain Reliever Infant Grape, 2 oz.

300676440590

67644059

10300676440597

2 oz

10115517

05/31/2013

10115518

05/31/2013

10115519

05/31/2013

10115522

05/31/2013

10123421

09/30/2013

10128599

11/30/2013

10130570

11/30/2013

Triaminic® Multi Symptom Fever, 3.4 oz.

300676394343

67639434

10300676394340

3.4 oz

10116856

06/30/2013

10116857

06/30/2013

10126948

09/30/2013

Triaminic® Syrups (Cont.)

PRODUCT

Item UPC NUMBER

NDC NUMBER

Case UCC NUMBER

Size

LOT

EXPIRY DATE

Triaminic® Multi Symptom Fever, 4 oz.

300436394040

67639404

10300436394047

4 oz

10110769

02/28/2013

10095563

03/31/2013

10102058

03/31/2013

10102271

05/31/2013

10116866

06/30/2013

10116867

06/30/2013

10116868

06/30/2013

10121656

08/31/2013

10126740

10/31/2013

10128836

11/30/2013

Triaminic® Night Time Cold and Cough, 3.4 oz.

300436344342

67634434

10300436344349

3.4 oz

10097303

03/31/2013

10097552

04/30/2013

10097554

06/30/2013

10108819

08/31/2013

10114273

12/31/2013

10126947

03/31/2014

Triaminic® Night Time Cold and Cough, 4 oz.

300436344045

67634404

10300436344042

4 oz

10094309

01/31/2013

10095895

03/31/2013

10097312

04/30/2013

10097313

04/30/2013

10104673

05/31/2013

10102054

06/30/2013

10106850

07/31/2013

10108823

08/31/2013

10111184

08/31/2013

10101373

11/30/2013

10114269

12/31/2013

10118449

12/31/2013

10121342A

12/31/2013

10121812

02/28/2014

10106851

03/31/2014

10126742

05/31/2014

Triaminic® Syrups (Cont.)

PRODUCT

Item UPC NUMBER

DIN

SCC

Size

LOT

Triaminic Chest & Nasal Congestion - Tropical Fruit

58478 10163 7

2278308

20058478101631

100 mL

All

Triaminic Cold & Cough- Cherry

58478 47100 6

2243739

20058478471000

100 mL

All

Triaminic Cold & Nighttime Cough - Grape

58478 47102 0

896179

20058478471024

100 mL

All

Triaminic Cough & Sore Throat - Grape

58478 47108 2

2130564

20058478471086

100 mL

All

Triaminic Long Acting Cough - Berry Punch

58478 10168 2

2277972

200058478101686

100 mL

All

Triaminic Total Cold, Cough & Fever - Bubble Gum

58478 47104 4

2239666

20058478471048

100 mL

All

Buckley´s® Complete Liquids

PRODUCT

Item UPC NUMBER

DIN

SCC

Size

LOT

Buckley's Complete with Mucus Relief Extra Strength

58478 10792 9

2357232

20058478107923

150 mL

All

Buckley's Complete with Mucus Relief Extra Strength

58478 10776 9

2357232

20058478107763

250 mL

All

Buckley's Complete PM - Nighttime

58478 10777 6

2356457

20058478107770

150 mL

All

Buckley's Complete

58478 10295 5

2279703

20058478102959

250 mL

All

Buckley's Complete

58478 10295 5

2279703

20058478102959

250 mL

All

Buckley's Complete

58478 10064 7

2279703

20058478100641

150 mL

All

Buckley's Complete

58478 10064 7

2279703

20058478100641

150 mL

All

Jack & Jill® Pediatric Syrups

PRODUCT

Item UPC NUMBER

DIN

SCC

Size

LOT

Jack & Jill Bedtime - Grape

65515 00010 5

2241167

10065515000102

100 mL

All

Jack & Jill Cough & Cold – Cherry

65515 00021 1

2242588

10065515000218

100 mL

All

Jack & Jill Children's Formula Cough Liquid - Cherry

65515 00019 8

823023

10065515000195

100 mL

All

Jack & Jill Cough Syrup - Raspberry

65515 00008 2

622036

10065515000089

100 mL

All

Jack & Jill Expectorant - Raspberry

58478 10798 1

2350084

20058478107985

100 mL

All

 

SOURCE Novartis Pharma Logistics, Inc.



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