Class II · ModerateRecall completed
POTASSIUM CHLORIDE in D 5 1/2NS
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberAll Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15
Where it was soldU.S. Including: VA, NC
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Sentara Enterprises |
Show the full FDA record
| Full product label | POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. |
| Recalling firm | Sentara Enterprises |
| Distribution | U.S. Including: VA, NC |
| Quantity | a) 7 Bags, b) 2 Bags |
| Recall initiated | 2015-09-18 |
| Report date | 2016-02-03 |
| Recall completed | 2016-06-29 |
| Recall number | D-0619-2016 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Chesapeake VA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.