Recalls / Class I
Class ID-0871-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: E52418EV11C, Exp 03/19/2016
Why it was recalled
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Recalling firm
- Firm
- Pharmakon Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 75 Syringes
- Distribution pattern
- IN and IL
Timeline
- Recall initiated
- 2016-02-11
- FDA classified
- 2016-05-25
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-05-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0871-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.