POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq ...
FDA Drug Recall #D-0619-2016 — Class II — September 18, 2015
Recall Summary
| Recall Number | D-0619-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 18, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sentara Enterprises |
| Location | Chesapeake, VA |
| Product Type | Drugs |
| Quantity | a) 7 Bags, b) 2 Bags |
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Distribution Pattern
U.S. Including: VA, NC
Lot / Code Information
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15
Other Recalls from Sentara Enterprises
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0620-2016 | Class II | Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a)... | Sep 18, 2015 |
| D-0636-2016 | Class II | Lactated Ringers, Packaged in a) 1500ML Homepum... | Sep 18, 2015 |
| D-0625-2016 | Class II | HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML ... | Sep 18, 2015 |
| D-0643-2016 | Class II | Dextrose-5% Lactated Ringers, Packaged in 3000M... | Sep 18, 2015 |
| D-0639-2016 | Class II | CLINDAMYCIN 120MG in NS, Package in 20ML Homepu... | Sep 18, 2015 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.