Manufactured by the Florida-based PharmaTech, the liquid drug or dietary supplement products were distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories.
The distributors have all issued voluntary recall of their respective products. The recalled products were distributed across wholesale and retail facilities that include hospitals and pharmacies throughout the US, stated the FDA.
Some of the recalled products include liquid docusate sodium drugs used for softening stools, dietary supplements like liquid vitamin D drops and liquid multivitamins targeting infants and children.
After being notified about the contamination issue, Rugby Laboratories had voluntarily recalled Diocto Syrup and Diocto Liquid earlier in the month.
According to the FDA, the three distributors based on additional details it provided had recalled all lots within expiry of all liquid products manufactured by it as a precautionary measure.
It added that the distributors had dispatched recall letters and had made arrangements to recover all recalled products.
The FDA has issued an advisory asking consumers, pharmacies and health care facilities to immediately stop using and dispensing all the recalled products.
FDA Commissioner Scott Gottlieb said: “B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems.
“These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online – making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.”