CLASS II Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Potassium Chloride For Injection Concentrate syringe recalled
Medi-Fare Drug and Home Health Center is recalling Potassium Chloride For Injection Concentrate syringe 40 mEq/ (2 mEq/mL), distributed in Texas. The recall was initiated on 3 Jul 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0919-2018
- FDA event ID
- 80453
- Recalling firm
- Medi-Fare Drug and Home Health Center, Blacksburg, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2018
- FDA classified
- 12 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Jul 2018 | Recall initiated by company | |
| 12 Jul 2018 | Classified by FDA | +9 days |
| 18 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Product as listed by the FDA
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
Where it was distributed
Texas only
Questions about this recall
Why was it recalled?
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Which lots are affected?
Lot: 20180522@1 Exp.: 08/20/18
Where was it sold?
Texas only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.