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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Related recalls
Same manufacturer · Pharmakon Pharmaceuticals
See all →- HighPharmakon Recalls Subpotent Epinephrine Injectable Syringes Nationwide
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03