PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported July 18, 2018

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

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

Recall #
D-0919-2018
Affected scope
1116 syringes
Initiated
July 3, 2018
Verify with FDA Drug →
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Medi-Fare Drug and Home Health Center recalled Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Me… - a moderate-severity action.

Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Me… was recalled by Medi-Fare Drug and Home Health Center in July 18, 2018. Reason: CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20m…. Check the official notice for the remedy. Verify recall #D-0919-2018 with the FDA Drug before acting.

The recall

Medi-Fare Drug and Home Health Center issued this moderate-severity FDA Drug recall-CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20m….

Moderate
severity level
Class II
classification
July 18, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0919-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0919-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on July 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medi-Fare Drug and Home Health Center is listed as the recalling firm, operating out of Blacksburg, SC. Federal records list the affected scope as 1116 syringes.

The documented reason for this recall is: CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. Distribution data in the federal record shows the product reached: Texas only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

1116 syringes

Related Recalls

6

5 from same agency

Product description

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

Reason for recall

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0919-2018
Date reported July 18, 2018
Date initiated July 3, 2018
Recalling firm Medi-Fare Drug and Home Health Center
Firm location Blacksburg, SC
Affected scope 1116 syringes
Distribution Texas only

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0919-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Medi-Fare Drug and Home Health Center. Units affected: 1116 syringes.
Why was this product recalled?
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0919-2018.
Where was the recalled product distributed?
Distribution: Texas only.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0919-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.