Novartis Pharma Logistics, Inc. voluntarily recalling in Barbados select lots of certain over-the-counter products due to bottle closure defect

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 Barbados 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.

{IMAGE VIA - savealoonie.com} 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.

{IMAGE VIAsavealoonie.com} 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.

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 at 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.

{IMAGE VIA -wbur.org} 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 Barbados

{IMAGE VIA -wbur.org} 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 Barbados

This recall is being conducted with the full knowledge of the Barbados Ministry of Health.

  • 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.

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
10116591A03/13/2013

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.

30043634604967634604103004363460464 oz1009251901/31/2013
1009650702/28/2013
1009251804/30/2013
1010234405/31/2013
1010205206/30/2013
1009850507/31/2013
1010651111/30/2013
1009919112/31/2013
1012292902/28/2014
1012595605/31/2014

Triaminic® Cough and

Sore Throat, 4 oz.

30043634804367634804103004363480404 oz1010467802/28/2013
1010702502/28/2013
1010702605/31/2013
1011768106/30/2013
1011805208/31/2013
1012685009/30/2013

Triaminic® Day Time

Cold and Cough, 4 oz.

30043634504267634504103004363450494 oz1009252001/31/2013
1009554501/31/2013
1011745302/28/2013
1009730803/31/2013
1009590404/30/2013
1009969905/31/2013
1010205306/30/2013
1010361607/31/2013
1010702408/31/2013
1010361709/30/2013
1011426610/31/2013
1011666011/30/2013
1011686912/31/2013
1011687002/28/2014
1012644503/31/2014

Triaminic®

Daytime/Nighttime Cold

& Cough Club Pack

300436417121N/A103004364171351009532701/31/2013
1009590701/31/2013
1009774801/31/2013
1009529804/30/2013
1011781712/31/2013
1011781803/31/2014
1011781903/31/2014

Triaminic®

Daytime/Nighttime Cold &

Cough Combo Pack

30043621608367621608103004362160801009590601/31/2013
1009921602/28/2013
1010079204/30/2013
1010079304/30/2013
1010149405/31/2013
1010149505/31/2013
1010684605/31/2013
1010467506/30/2013
1010608606/30/2013
1010608807/31/2013
1010628407/31/2013
1010684808/31/2013
1011096808/31/2013
1011314609/30/2013
1011314711/30/2013
1011503711/30/2013
1011659212/31/2013

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

1011659512/31/2013
1011659612/31/2013
1011659903/31/2014
1012338303/31/2014
1012338803/31/2014

Triaminic® Dye?free Long

Acting Cough, 4 oz.

30043635004667635004103004363500434 oz1008194204/30/2013
1008228304/30/2013
1008194006/30/2013
1009708207/31/2013
1008292709/30/2013
1009589310/31/2013
1009589410/31/2013
1010204911/30/2013
1010204812/31/2013
1010625112/31/2013
1010205101/31/2014
1010702102/28/2014
1010702205/31/2014
1011843007/31/2014
1012152908/31/2014
1012917011/30/2014

Triaminic® Fever Reducer

Pain Reliever Bubblegum,

4 oz.

30043643204967643204103004364320464 oz1009394101/31/2013
1010227002/28/2013
1011242303/31/2013
1010633405/31/2013
1011689108/31/2013

Triaminic® Fever Reducer

Pain Reliever Grape, 4 oz.

30043643104267643104103004364310494 oz1009271901/31/2013
1010853002/28/2013
1011242203/31/2013
1010633505/31/2013
1009393908/31/2013
1012647010/31/2013
1012762911/30/2013
1013055011/30/2013

Triaminic® Fever Reducer

Pain Reliever Infant

Bubblegum, 2 oz.

30067644159767644159103006764415942 oz1011551505/31/2013
1011551605/31/2013
1011552005/31/2013
1011552105/31/2013
1011956709/30/2013
1012858911/30/2013

Triaminic® Fever Reducer

Pain Reliever Infant Grape,

2 oz.

30067644059067644059103006764405972 oz1011551705/31/2013
1011551805/31/2013
1011551905/31/2013
1011552205/31/2013
1012342109/30/2013
1012859911/30/2013
1013057011/30/2013

Triaminic® Multi

Symptom Fever, 3.4 oz.

30067639434367639434103006763943403.4 oz1011685606/30/2013
1011685706/30/2013
1012694809/30/2013

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
10121342A12/31/2013

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

 

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