PharmaTech – Recall of Liquid Products

• On August 8, 2016, the FDA announced that PharmaTech 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.

• Below is a list of the recalled products. To date, PharmaTech has not received any complaints of contamination in the products and the associated lot numbers.

Recalled Liquid Drug Products Product Strength/ Company NDC Lot # Expiration Date Name Dosage Form 20391515, 8/2017 20391516 20391517 9/2017 20391518 10/2017 20391520 11/2017 20391521 12/2017 Rugby Senexion Liquid 237mL 00536-1000-59 20391601 1/2018 20391603, 3/2018 20391604 20391606, 4/2018 20391607 20391609 6/2018 22941505 10/2017 Rugby Diocto Syrup 60 mg/15 mL 0536-1001-85 22941601 1/2018 22941602 3/2018 20391517 9/2017 20391518 10/2017 20391519 11/2017 20391601, Major Senna Syrup 237 mL 0904-6289-09 2/2018 20391602 20391604, 3/2018 20391605 20391608 6/2018 Bayshore Aller-chlor Antihistamine 120 mL 00536-1025-47 23261501 10/2017 Bayshore Sennazon Syrup 237 mL 76518-0100-08 20391519 11/2017 Centurion Ninjacof 473 mL 23359-030-16 25291601 3/2018 Centurion Ninjacof A 473 mL 23359-033-16 25321601 4/2018 28601502 11/2017 28601601 1/2018 Virtrate-2, Sodium Virtus 473 mL 69543-367-16 28601602 3/2018 Citrate-Citric Acid 28601603, 6/2018 28601604 Virtrate-K, Potassium 28891502, Virtus 473 mL 69543-262-16 12/2017 Citrate and Citric Acid 28891503 Recalled Liquid Dietary Supplement Products Calcionate Syrup, Calcium Glubionate 473 mL 00536-2770-85 20341601 6/2018 Syrup Rugby 20471516, Cerovite Liquid 236 mL 00536-2790-59 20471517, 11/2017 20471518,

20471519, 20471520 20471521 12/2017 20471601 1/2018 20471608 4/2018 20471610, 5/2018 20471613 20471614 6/2018 20691509 11/2017 20691601 1/2018 Rugby D3 Vitamin Liquid 50 mL 00536-8400-80 20691602 2/2018 20691604 5/2018 22461511, 10/2017 22461512 22461513, 11/2017 22461514 22461515, 12/2017 22461516, Rugby Ferrous Sulfate Liquid 473 mL 00536-0650-85 22461601, 2/2018 22461602 22461603, 4/2018 22461604 22461605, 5/2018 22461606 20901507 7/2017 Rugby Fer-iron Liquid 50 mL 00536-0710-80 20901508 11/2017 20901603 5/2018 21021510 7/2017 Polyvitamin liquid with 21021601 1/2018 Rugby 50 mL 0904-5100-50 Iron 21021602 2/2018 21021604 5/2018 20701511 9/2018 20701514 12/2017 Rugby Polyvitamin liquid 50 mL 00904-5099-50 20701605 5/2018 20701606 6/2018 20731506 8/2017 Rugby Tri-Vitamin liquid 50 mL 00536-8501-80 20731603 2/2018 20731604 6/2018 20331510, 12/2017 20331511 Rugby Liquid Vitamin C 118 mL 00536-0160-97 20331601, 3/2018 20331602 20471602 1/2018 20471603, 2/2018 20471604 20471605, CertaVite with 3/2018 Major 236 mL 0904-5023-09 20471606 Antioxidants 20471607 4/2018 20471609, 20471611, 5/2018 20471612 20701509, 9/2017 20701511 20701513 12/2017 Major Poly-Vita Drops 50 mL 0904-5099-50 20701601 2/2018 20701602 4/2018 20701603 4/2018 20701606 6/2018 21021510 7/2017 21021601 1/2018 Major Poly-Vita Drops with Iron 50 mL 0904-5100-50 21021602 2/2018 21021603 4/2018 21021604 5/2018 20691509 11/2017 20691510 12/2017 Major D-Vita Drops 50 mL 0904-6273-50 20691603 3/2018 20691605 4/2018 20901509, 11/2017 20901510 Major Ferrous Drops 50 mL 0904-6060-50 20901601 2/2018 20901602 3/2018 20901603 5/2018 Major Tri-Vita Drops 50 mL 0904-6274-50 20731506 8/2017

20731507 11/2017 20731604, 6/2018 20731605 20731506 8/2017 Bayshore Pedia Tri-Vite Drops 50 mL 76518-020-50 20731508 11/2017 Pedia Tri-Vite Drops with Bayshore 50 mL 76518-040-50 21021511 11/2017 Iron Bayshore Pedia Poly-Vite Drops 50 mL 76518-030-50 20701512 11/2017 Bayshore Pedia D-Vite Drops 50 mL 76518-050-50 20691509 11/2017 30161601 1/2018 Renew HC, Hydrolyzed Metron 30 mL -- 30161602, Clinoptilolite 3/2018 30161603 CytoDetox, Hydrolyzed Metron 30 mL -- 30661601 5/2018 Clinoptiloolite Fragments

• 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 can contact PharmaTech at 754-701-8320. Consumers can contact their physician or healthcare provider if they have additional questions about these products.

• PharmaTech is working to notify customers who may be in possession of the affected products. PharmaTech is notifying its distributors and customers by recall letter and is arranging for return of all recalled products.

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