Reported May 23, 2018 · Terminated
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic…
Rockwell Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rockwell Medical, Inc · 30142 S. Wixom Rd. · Wixom, MI · 48393-3440
Is this the product you have?
- DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
- Lot codes and dates
- Lot 28562-0220171
- Amount recalled
- 139
Where it was sold
Why it was recalled
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Rockwell Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.