FDA recall D-0871-2016

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.

Distribution

IN and IL

Key facts

Status

Terminated

Initiation date

2016-02-11

Report date

2016-06-01

Termination date

2017-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2016