PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination

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Announcement

PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population.

As part of its commitment to patient safety, PharmaTech, LLC is working to notify customers who may be in possession of the affected products. PharmaTech-LLC has not received any complaints to date of contamination in the products and the associated lot numbers. Please see the attachment for affected products and lot numbers.

PharmaTech, LLC is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.

Consumers with questions regarding this recall should contact Angelina Reyburn, Recall Coordinator at (754) 701-8320, Monday through Friday 8a - 5p EST. Consumers can contact their physician or healthcare provider if they have additional questions about these products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
• Regular Mail or Fax: Download form: www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-address form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the full knowledge of the U.S Food and Drug Administration.

About Pharmatech-LLC
PharmaTech-LLC is a leading provider of high-quality, Over the Counter, vitamin, and nutritional supplements products. PharmaTech-LLC is a full service GMP Contract Development and Manufacturing Organization offering services to clients worldwide. Services includes Research & Development for OTC & Rx products and Manufacturing services for Solid, Semi-Solids and Liquids.

Drug Products

Rugby:

• Diocto Syrup, Docusate Sodium 60mg/15 mL, NDC 0536-1001-85, Lot#22941505, Exp. Date 10/2017
• Diocto Syrup, Docusate Sodium 60mg/15 mL, NDC 0536-1001-85, Lot#22941601, Exp. Date 01/2018
• Diocto Syrup, Docusate Sodium 60mg/15 mL, NDC 0536-1001-85, Lot#22941602, Exp. Date 03/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391515, Exp. Date 08/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391516, Exp. Date 08/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391517, Exp. Date 09/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391518, Exp. Date 10/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391520, Exp. Date 11/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391521, Exp. Date 12/2017
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391601, Exp. Date 01/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391603, Exp. Date 03/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391604, Exp. Date 03/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391606, Exp. Date 04/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391607, Exp. Date 04/2018
• Senexion Liquid, 237mL, NDC 0536-1000-59, Lot#20391609, Exp. Date 06/2018

Major:

• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391517, Exp. Date 09/2017
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391518, Exp. Date 10/2017
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391519, Exp. Date 11/2017
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391601, Exp. Date 01/2018
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391602, Exp. Date 02/2018
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391604, Exp. Date 03/2018
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391605, Exp. Date 03/2018
• Senna Syrup, 237mL, NDC 0904-6289-09, Lot#20391608, Exp. Date 06/2018

Bayshore:

• Aller-chlor Antihistamine 120 mL, NDC 0536-1025-47, Lot# 23261501, Exp. Date 10/2017
• Sennazon Syrup, 237mL, NDC 7651810008, Lot#20391519, Exp. Date 11/2017

Centurion:

• Ninjacof, 473mL, NDC 23359-030-16, Lot#25291601, Exp. Date 03/2018
• Ninjacof A, 473mL, NDC 22359-033-16, Lot#25321601, Exp. Date 04/2018

Virtus:

• Virtrate-2, Sodium Citrate-Citric Acid, 473mL, NDC 69543-367-16, Lot#28601502, Exp. Date 11/2017
• Virtrate-2, Sodium Citrate-Citric Acid, 473mL, NDC 69543-367-16, Lot#28601601, Exp. Date 01/2018
• Virtrate-2, Sodium Citrate-Citric Acid, 473mL, NDC 69543-367-16, Lot#28601602, Exp. Date 03/2018
• Virtrate-2, Sodium Citrate-Citric Acid, 473mL, NDC 69543-367-16, Lot#28601603, Exp. Date 06/2018
• Virtrate-2, Sodium Citrate-Citric Acid, 473mL, NDC 69543-367-16, Lot#28601604, Exp. Date 06/2018
• Virtrate-K, Potassium Citrate and Citric Acid, 473mL, NDC 69543-262-16, Lot#28891502, Exp. Date 12/2017
• Virtrate-K, Potassium Citrate and Citric Acid, 473mL, NDC 69543-262-16, Lot#28891503, Exp. Date 12/2017

DIETARY SUPPLEMENT PRODUCTS

Rugby:

• Calcionate Syrup, Calcium Glubionate Syrup 473mL, UPC 005362770851, Lot#20341601, Exp. Date 06/2018
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471516, Exp. Date 11/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471517, Exp. Date 11/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471518, Exp. Date 11/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471519, Exp. Date 11/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471520, Exp. Date 11/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471521, Exp. Date 12/2017
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471601, Exp. Date 01/2018
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471608, Exp. Date 04/2018
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471610, Exp. Date 05/2018
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471613, Exp. Date 05/2018
• Cerovite Liquid, 236mL, UPC 005362790590, Lot#20471614, Exp. Date 06/2018
• D3 Vitamin Liquid, 50mL, UPC 005368400806, Lot#20691509, Exp. Date 11/2017
• D3 Vitamin Liquid, 50mL, UPC 005368400806, Lot#20691601, Exp. Date 01/2018
• D3 Vitamin Liquid, 50mL, UPC 005368400806, Lot#20691602, Exp. Date 02/2018
• D3 Vitamin Liquid, 50mL, UPC 005368400806, Lot#20691604, Exp. Date 05/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461511, Exp. Date 10/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461512, Exp. Date 10/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461513, Exp. Date 11/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461514, Exp. Date 11/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461515, Exp. Date 12/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461516, Exp. Date 12/2017
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461601, Exp. Date 02/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461602, Exp. Date 02/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461603, Exp. Date 04/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461604, Exp. Date 04/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461605, Exp. Date 05/2018
• Ferrous Sulfate Liquid, 473mL, UPC 005360650858, Lot#22461606, Exp. Date 05/2018
• Fer-iron Liquid, 50mL, UPC 005360710804, Lot#20901507, Exp. Date 07/2017
• Fer-iron Liquid, 50mL, UPC 005360710804, Lot#20901508, Exp. Date 11/2017
• Fer-iron Liquid, 50mL, UPC 005360710804, Lot#20901603, Exp. Date 05/2018
• Polyvitamin liquid with Iron, 50mL, NDC 0904-5100-50, Lot#21021510, Exp. Date 07/2017
• Polyvitamin liquid with Iron, 50mL, NDC 0904-5100-50, Lot#21021601, Exp. Date 01/2018
• Polyvitamin liquid with Iron, 50mL, NDC 0904-5100-50, Lot#21021602, Exp. Date 02/2018
• Polyvitamin liquid with Iron, 50mL, NDC 0904-5100-50, Lot#21021604, Exp. Date 05/2018
• Polyvitamin liquid, 50mL, NDC 0904-5099-50, Lot#20701511, Exp. Date 09/2018
• Polyvitamin liquid, 50mL, NDC 0904-5099-50, Lot#20701514, Exp. Date 12/2017
• Polyvitamin liquid, 50mL, NDC 0904-5099-50, Lot#20701605, Exp. Date 05/2018
• Polyvitamin liquid, 50mL, NDC 0904-5099-50, Lot#20701606, Exp. Date 06/2018
• Tri-Vitamin liquid, 50mL, UPC 005368501800, Lot#20731506, Exp. Date 08/2017
• Tri-Vitamin liquid, 50mL, UPC 005368501800, Lot#20731603, Exp. Date 02/2018
• Tri-Vitamin liquid, 50mL, UPC 005368501800, Lot#20731604, Exp. Date 06/2018
• Liquid Vitamin C, 118 mL, UPC 005360160975, Lot#20331510, Exp. Date 12/2017
• Liquid Vitamin C, 118 mL, UPC 005360160975, Lot#20331511, Exp. Date 12/2017
• Liquid Vitamin C, 118 mL, UPC 005360160975, Lot#20331601, Exp. Date 03/2018
• Liquid Vitamin C, 118 mL, UPC 005360160975, Lot#20331602, Exp. Date 03/2018

Major:

• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471602, Exp. Date 01/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471603, Exp. Date 02/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471604, Exp. Date 02/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471605, Exp. Date 03/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471606, Exp. Date 03/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471607, Exp. Date 04/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471609, Exp. Date 05/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471611, Exp. Date 05/2018
• CertaVite with Antioxidants, 236mL, NDC 0904-5023-09, Lot#20471612, Exp. Date 05/2018
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701509, Exp. Date 09/2017
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701511, Exp. Date 09/2017
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701513, Exp. Date 12/2017
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701601, Exp. Date 02/2018
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701602, Exp. Date 04/2018
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701603, Exp. Date 04/2018
• Poly-Vita Drops, 50mL, NDC 0904-5099-50, Lot#20701606, Exp. Date 06/2018
• Poly-Vita Drops with Iron, NDC 0904-5100-50, Lot#21021510, Exp. Date 07/2017
• Poly-Vita Drops with Iron, NDC 0904-5100-50, Lot#21021601, Exp. Date 01/2018
• Poly-Vita Drops with Iron, NDC 0904-5100-50, Lot#21021602, Exp. Date 02/2018
• Poly-Vita Drops with Iron, NDC 0904-5100-50, Lot#21021603, Exp. Date 04/2018
• Poly-Vita Drops with Iron, NDC 0904-5100-50, Lot#21021604, Exp. Date 05/2018
• D-Vita Drops, 50mL, NDC 0904-6273-50, Lot#20691509, Exp. Date 11/2017
• D-Vita Drops, 50mL, NDC 0904-6273-50, Lot#20691510, Exp. Date 12/2017
• D-Vita Drops, 50mL, NDC 0904-6273-50, Lot#20691603, Exp. Date 03/2018
• D-Vita Drops, 50mL, NDC 0904-6273-50, Lot#20691605, Exp. Date 04/2018
• Ferrous Drops, 50mL, NDC 0904-6060-50, Lot#20901509, Exp. Date 11/2017
• Ferrous Drops, 50mL, NDC 0904-6060-50, Lot#20901510, Exp. Date 11/2017
• Ferrous Drops, 50mL, NDC 0904-6060-50, Lot#20901601, Exp. Date 02/2018
• Ferrous Drops, 50mL, NDC 0904-6060-50, Lot#20901602, Exp. Date 03/2018
• Ferrous Drops, 50mL, NDC 0904-6060-50, Lot#20901603, Exp. Date 05/2018
• Tri-Vita Drops, 50mL, NDC 0904-6274-50, Lot#20731506, Exp. Date 08/2017
• Tri-Vita Drops, 50mL, NDC 0904-6274-50, Lot#20731507, Exp. Date 11/2017
• Tri-Vita Drops, 50mL, NDC 0904-6274-50, Lot#20731604, Exp. Date 06/2018
• Tri-Vita Drops, 50mL, NDC 0904-6274-50, Lot#20731605, Exp. Date 06/2018

Bayshore:

• Pedia Tri-Vite Drops, 50mL, NDC 76518-020-50, Lot#20731506, Exp. Date 08/2017
• Pedia Tri-Vite Drops, 50mL, NDC 76518-020-50, Lot#20731508, Exp. Date 11/2017
• Pedia Tri-Vite Drops with Iron, 50mL, NDC 76518-040-50, Lot#21021511, Exp. Date 11/2017
• Pedia Poly-Vite Drops, 50mL, NDC 76518-030-50, Lot#20701512, Exp. Date 11/2017
• Pedia D-Vite Drops, 50mL, NDC 76518-050-50, Lot#20691509, Exp. Date 11/2017

Metron:

• Renew HC, Hydrolyzed Clinoptilolite, 30mL, Lot#30161601, Exp. Date 01/2018
• Renew HC, Hydrolyzed Clinoptilolite, 30mL, Lot#30161602, Exp. Date 03/2018
• Renew HC, Hydrolyzed Clinoptilolite, 30mL, Lot#30161603, Exp. Date 03/2018
• CytoDetox, Hydrolyzed Clinoptiloolite Fragments, 30mL, UPC 632687615989, Lot#30661601, Exp. Date 05/2018