Recall record at a glance
| Official record | Z-1811-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Church & Dwight Inc. |
| Report date | Jul 31, 2013 |
| Recall initiation date | Jun 11, 2013 |
| Quantity | 234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2 |
| Location | Princeton, NJ, United States |
Official product description
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
Why the product was recalled
Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.
Distribution information
Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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