Church & Dwight Recalls Contaminated Sodium Bicarbonate for Medical Use

Plain-English summary

Church & Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced at its Old Fort, OH facility. The recall affects specific lots of Dialysis Grade 1.5 and Dialysis Grade 2 sodium bicarbonate that are used as an active pharmaceutical ingredient (API) or excipient in the manufacture of medical devices and drugs.

The recall was initiated due to metal and other contamination. The affected product was distributed nationwide, including to Illinois, Pennsylvania, Indiana, Ohio, Michigan, Tennessee, Texas, Minnesota, Missouri, New Jersey, Kentucky, and Maryland. The recall includes 234 sacks of Dialysis Grade 1.5 and 880 bags of Dialysis Grade 2.

Consumers and healthcare facilities should check their inventory for the specific lot numbers FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158. If these lots are found, they should be removed from use and returned to the supplier or the recalling firm.

The recalled product

Product

Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

Manufacturer

Church & Dwight Inc

Category

Medical Device — Raw Material / API

Hazard

• metal-contamination
• foreign-object

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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