Pharmakon Recalls Morphine Sulfate Syringes Due to High Potency
Pharmakon Pharmaceuticals is recalling 75 syringes of Morphine Sulfate 0.5 mg/mL due to out-of-specification potency results indicating high levels.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 75 syringes of Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride. The product is a compounded drug intended for intravenous use, identified by NDC 45183-0322-78. The specific lot affected is E52418EV11C, with an expiration date of 03/19/2016.
The recall was initiated because out-of-specification potency results (high) were obtained for this lot of morphine sulfate injection. The agency classifies this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected product was distributed in Indiana and Illinois. Healthcare providers and patients should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 75
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 (2)
- Lot #: E52418EV11C
- Exp 03/19/2016
Distribution
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