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Recall 2017-140A: Rugby/Major/Leader - Liquid Products - NYC - Consumer


URGENT!!!   DRUG RECALL!!!   URGENT!!!

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.

The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC. Please see the below list of affected products.

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC.

The distribution firms are notifying their distributors and customers by recall letter and are arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. - 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. - 7p.m. and Friday 8 a.m. - 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

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:

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


PRODUCT NAME NDC# LOTS EXPIRATION DATE
ALLER-CHLOR 2 MG/5 ML SYRUP    00536102547 ALL ALL
CALCIONATE 1.8 GM/5 ML SYRUP   00536277085 ALL ALL
CEROVITE LIQUID                00536279059 ALL ALL
CERTAVITE-ANTIOXIDANT LIQUID   00904502309 ALL ALL
DIOCTO 50 MG/5 ML LIQUID       00536059085 ALL ALL
DIOCTO 60 MG/15 ML SYRUP       00536100185 ALL ALL
D-VITA 400 UNIT/ML DROP        00904627350 ALL ALL
FER-IRON 15 MG/1 ML DROPS      00536071080 ALL ALL
FERROUS SULF 15 MG IRON/ML DRP 00904606050 ALL ALL
FERROUS SULF 220 MG/5 ML ELIX  00536065085 ALL ALL
POLY-VITAMIN DROPS             00536845080 ALL ALL
POLYVITAMIN W-IRON DROPS       00536853080 ALL ALL
SENEXON 8.8 MG/5 ML LIQUID     00536100059 ALL ALL
SENNA 8.8 MG/5 ML SYRUP        00904628909 ALL ALL
TRI-VITAMIN DROPS              00536850180 ALL ALL
TRI-VITA DROPS                 00904627450 ALL ALL
VITAMIN C 500 MG/5 ML LIQUID   00536016097 ALL ALL
VITAMIN D3 400 UNIT/ML DROP    00536840080 ALL ALL
POLY-VITA DROPS                00904509950 ALL ALL
POLY-VITA WITH IRON DROPS      00904510050 ALL ALL

Contact:

Major, Rugby, and Leader: Major Rugby Leader Customer Service 800-645-2158