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