Medi-Fare Recalls Potassium Chloride Syringes Due to Fill Volume Error
Medi-Fare Drug and Home Health Center is recalling 1,116 syringes of Potassium Chloride For Injection Concentrate because they were filled with 19 mL instead of the labeled 20 mL.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling/fill volume error (19 mL vs 20 mL) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medi-Fare Drug and Home Health Center is recalling 1,116 syringes of Potassium Chloride For Injection Concentrate, 40 mEq/20 mL (2 mEq/mL). The product is prescription-only and was distributed in Texas. The specific lot number is 20180522@1, with an expiration date of 08/20/18.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The syringes were filled with 19 mL of potassium chloride, while the labels displayed a fill volume of 20 mL. This discrepancy represents a labeling and fill volume error.
Consumers and healthcare providers who have this specific product should stop using it and contact Medi-Fare Drug and Home Health Center at 800-622-0007 for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Medi-Fare Drug and Home Health Center
- Category
- Drug — Injectable
- Affected units
- 1,116
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 20180522@1 Exp.: 08/20/18
Distribution
Distributed in 1 state:
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