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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.
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Novartis Media RelationsJulie MasowNovartis Corporation
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+1 862 579 8456 (mobile)
Pamela McKinlayNovartis Consumer Health, Inc.
+1 973 503 7337(direct)
+1 862 221 0151(mobile)
e-mail: us.mediarelations@novartis.com Milicent BrooksNovartis Consumer Health, Inc.
+1 973 503 7483(direct)
+1 973 479 2078 (mobile)
Francisco EricastillaNovartis Farmaceutica, S.A. (AC)
+502 242 28438 (direct)
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francisco.ericastilla@novartis.com
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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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