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Novartis Pharma Logistics, Inc. voluntarily recalling in Aruba select lots of certain over-the-counter products due to bottle closure defect
Date:2/5/2013

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 Aruba 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 the US prior to the voluntary suspension of operations in December 2011. In addition to production in the US, 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 Aruba 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 RelationsJulie MasowNovartis Corporation

+1 212 830 2465 (direct)

+1 862 579 8456 (mobile)

julie.masow@novartis.com

 

Pamela McKinlayNovartis Consumer Health, Inc.

+1 973 503 7337(direct)

+1 862 221 0151(mobile)

pamela.mckinlay@novartis.com Milicent BrooksNovartis Consumer Health, Inc.

+1 973 503 7483(direct)

+1 973 479 2078 (mobile)

milicent.brooks@novartis.com

 

Francisco EricastillaNovartis Farmaceutica, S.A. (AC)

+502 242 28438 (direct)

+502 571 09426 (mobile)

francisco.ericastilla@novartis.com e-mail: us.mediarelations@novartis.com For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis.
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Theraflu Warming Relief® SyrupsPRODUCTItem UPC NUMBERNDC NUMBERCase UCC NUMBERSizeLOTEXPIRY DATETheraflu ® Warming
Relief Flu and Sore
Throat, 8.3 oz.

300436265081

43626508

10300436265088

8.3 oz

10108935

03/31/201310096570

05/31/201310121298

05/31/201310123035

05/31/201310106483

06/30/201310126716

07/31/2013Theraflu® Daytime
Warming Relief Severe
Cold and Cough, 8.3 oz.

300430461083

43046108

10300430461080

8.3 oz

10096571

04/30/201310117845

04/30/201310102070

06/30/201310118134

06/30/201310118135

08/31/201310126586

08/31/201310126729

10/31/2013Theraflu®
Daytime/Nighttime Severe
Cold & Cough Value Pack

300436412164

67641216

1030043641216110120065

03/01/201310116591A

03/13/201310116591

03/31/201310116593

03/31/201310106487

05/31/201310108285

05/31/201310116594

06/30/201310116597

06/30/201310116598

06/30/201310116600

06/30/201310116601

08/31/201310116602

08/31/2013Theraflu® Nighttime
Warming Relief Severe
Cold and Cough, 8.3 oz.

300430460086

43046008

10300430460083

8.3 oz

10104954

04/30/201310104955

05/31/201310107018

05/31/201310118113

05/31/201310123039

05/31/201310104956

07/31/201310126861

08/31/2013Theraflu® Warming Relief
Cold and Chest
Congestion, 8.3 oz.

300436296085

43629608

10300436296082

8.3 oz

10106482

01/31/201310102071

07/31/201310113497

07/31/201310122891

08/31/201310123274

08/31/201310126440

09/30/201310128457

11/30/2013Theraflu® Warming Relief
Sinus and Cold, 8.3 oz.

300436407085

67640708

10300436407082

8.3 oz

10095358

04/30/201310104966

07/31/2013Triaminic® Syrups PRODUCTItem UPC NUMBERNDC NUMBERCase UCC NUMBERSizeLOTEXPIRY DATETriaminic® Cold and
Allergy, 4 oz.

300436346049

67634604

10300436346046

4 oz

10092519

01/31/201310096507

02/28/201310092518

04/30/201310102344

05/31/201310102052

06/30/201310098505

07/31/201310106511

11/30/201310099191

12/31/201310122929

02/28/201410125956

05/31/2014Triaminic® Cough and
Sore Throat, 4 oz.

300436348043

67634804

10300436348040

4 oz

10104678

02/28/201310107025

02/28/201310107026

05/31/201310117681

06/30/201310118052

08/31/201310126850

09/30/2013Triaminic® Day Time
Cold and Cough, 4 oz.

300436345042

67634504

10300436345049

4 oz

10092520

01/31/201310095545

01/31/201310117453

02/28/201310097308

03/31/201310095904

04/30/201310099699

05/31/201310102053

06/30/201310103616

07/31/201310107024

08/31/201310103617

09/30/201310114266

10/31/201310116660

11/30/201310116869

12/31/201310116870

02/28/201410126445

03/31/2014Triaminic®
Daytime/Nighttime Cold
& Cough Club Pack

300436417121

N/A

1030043641713510095327

01/31/201310095907

01/31/201310097748

01/31/201310095298

04/30/201310117817

12/31/201310117818

03/31/201410117819

03/31/2014Triaminic®
Daytime/Nighttime Cold &
Cough Combo Pack

300436216083

67621608

1030043621608010095906

01/31/201310099216

02/28/201310100792

04/30/201310100793

04/30/201310101494

05/31/201310101495

05/31/201310106846

05/31/201310104675

06/30/201310106086

06/30/201310106088

07/31/201310106284

07/31/201310106848

08/31/201310110968

08/31/201310113146

09/30/201310113147

11/30/201310115037

11/30/201310116592

12/31/2013Triaminic® Syrups (Cont.)PRODUCTItem UPC NUMBERNDC NUMBERCase UCC NUMBERSizeLOTEXPIRY DATETriaminic®
Daytime/Nighttime Cold
& Cough Combo Pack
(Cont.)

300436216083

67621608

1030043621608010116595

12/31/201310116596

12/31/201310116599

03/31/201410123383

03/31/201410123388

03/31/2014Triaminic® Dye‐free Long
Acting Cough, 4 oz.

300436350046

67635004

10300436350043

4 oz

10081942

04/30/201310082283

04/30/201310081940

06/30/201310097082

07/31/201310082927

09/30/201310095893

10/31/201310095894

10/31/201310102049

11/30/201310102048

12/31/201310106251

12/31/201310102051

01/31/201410107021

02/28/201410107022

05/31/201410118430

07/31/201410121529

08/31/201410129170

11/30/2014Triaminic® Fever Reducer
Pain Reliever Bubblegum,
4 oz.

300436432049

67643204

10300436432046

4 oz

10093941

01/31/201310102270

02/28/201310112423

03/31/201310106334

05/31/201310116891

08/31/2013Triaminic® Fever Reducer
Pain Reliever Grape, 4 oz.

300436431042

67643104

10300436431049

4 oz

10092719

01/31/201310108530

02/28/201310112422

03/31/201310106335

05/31/201310093939

08/31/201310126470

10/31/201310127629

11/30/201310130550

11/30/2013Triaminic® Fever Reducer
Pain Reliever Infant
Bubblegum, 2 oz.

300676441597

67644159

10300676441594

2 oz

10115515

05/31/201310115516

05/31/201310115520

05/31/201310115521

05/31/201310119567

09/30/201310128589

11/30/2013Triaminic® Fever Reducer
Pain Reliever Infant Grape,
2 oz.

300676440590

67644059

10300676440597

2 oz

10115517

05/31/201310115518

05/31/201310115519

05/31/201310115522

05/31/201310123421

09/30/201310128599

11/30/201310130570

11/30/2013Triaminic® Multi
Symptom Fever, 3.4 oz.

300676394343

67639434

10300676394340

3.4 oz

10116856

06/30/201310116857

06/30/201310126948

09/30/2013Triaminic® Syrups (Cont.)PRODUCTItem UPC NUMBERNDC NUMBERCase UCC NUMBERSizeLOTEXPIRY DATETriaminic® Multi
Symptom Fever, 4 oz.

300436394040

67639404

10300436394047

4 oz

10110769

02/28/201310095563

03/31/201310102058

03/31/201310102271

05/31/201310116866

06/30/201310116867

06/30/201310116868

06/30/201310121656

08/31/201310126740

10/31/201310128836

11/30/2013Triaminic® Night Time
Cold and Cough, 3.4 oz.

300436344342

67634434

10300436344349

3.4 oz

10097303

03/31/201310097552

04/30/201310097554

06/30/201310108819

08/31/201310114273

12/31/201310126947

03/31/2014Triaminic® Night Time
Cold and Cough, 4 oz.

300436344045

67634404

10300436344042

4 oz

10094309

01/31/201310095895

03/31/201310097312

04/30/201310097313

04/30/201310104673

05/31/201310102054

06/30/201310106850

07/31/201310108823

08/31/201310111184

08/31/201310101373

11/30/201310114269

12/31/201310118449

12/31/201310121342A

12/31/201310121812

02/28/201410106851

03/31/201410126742

05/31/2014Triaminic® Syrups (Cont.) PRODUCTItem UPC NUMBERDINSCCSizeLOTTriaminic Chest & Nasal
Congestion - Tropical Fruit

58478 10163 7

2278308

20058478101631

100 mL

AllTriaminic Cold & Cough- Cherry

58478 47100 6

2243739

20058478471000

100 mL

AllTriaminic Cold & Nighttime Cough
- Grape

58478 47102 0

896179

20058478471024

100 mL

AllTriaminic Cough & Sore Throat -
Grape

58478 47108 2

2130564

20058478471086

100 mL

AllTriaminic Long Acting Cough -
Berry Punch

58478 10168 2

2277972

200058478101686

100 mL

AllTriaminic Total Cold, Cough &
Fever - Bubble Gum

58478 47104 4

2239666

20058478471048

100 mL

AllBuckley's® Complete Liquids PRODUCTItem UPC NUMBERDINSCCSizeLOTBuckley's Complete with Mucus
Relief Extra Strength

58478 10792 9

2357232

20058478107923

150 mL

AllBuckley's Complete with Mucus
Relief Extra Strength

58478 10776 9

2357232

20058478107763

250 mL

AllBuckley's Complete PM - Nighttime

58478 10777 6

2356457

20058478107770

150 mL

AllBuckley's Complete

58478 10295 5

2279703

20058478102959

250 mL

AllBuckley's Complete

58478 10295 5

2279703

20058478102959

250 mL

AllBuckley's Complete

58478 10064 7

2279703

20058478100641

150 mL

AllBuckley's Complete

58478 10064 7

2279703

20058478100641

150 mL

AllJack & Jill® Pediatric SyrupsPRODUCTItem UPC NUMBERDINSCCSizeLOTJack & Jill Bedtime - Grape

65515 00010 5

2241167

10065515000102

100 mL

AllJack & Jill Cough & Cold – Cherry

65515 00021 1

2242588

10065515000218

100 mL

AllJack & Jill Children's Formula
Cough Liquid - Cherry

65515 00019 8

823023

10065515000195

100 mL

AllJack & Jill Cough Syrup -
Raspberry

65515 00008 2

622036

10065515000089

100 mL

AllJack & Jill Expectorant - Raspberry

58478 10798 1

2350084

20058478107985

100 mL

All


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SOURCE Novartis Pharma Logistics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

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