FDA Recall D-0871-2016
Pharmakon Pharmaceuticals · Noblesville, IN
Class I — life-threatening Terminated 460 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Recall record
- Recall number
D-0871-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- IN and IL
- Recall initiated
- 2016-02-11
- Classified by FDA Center
- 2016-05-25
- FDA published
- 2016-06-01
- Terminated
- 2017-05-16
- Recalling firm
- Pharmakon Pharmaceuticals
- Firm location
- Noblesville, IN