A massive recall is underway by PharmaTech due to Burkholderia cepacia contamination affecting a number of liquid drug and supplement products sold nationwide.
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.
Drug Products
Continue Reading Below ↓↓↓
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
Continue Reading Below ↓↓↓
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
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.
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.
