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.
Reported: June 1, 2016 Initiated: February 11, 2016 #D-0871-2016
Product Description
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.
Reason for Recall
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Details
- Recalling Firm
- Pharmakon Pharmaceuticals
- Units Affected
- 75 Syringes
- Distribution
- IN and IL
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmakon Pharmaceuticals. Units affected: 75 Syringes.
Why was this product recalled? ▼
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0871-2016.
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