FDA Recall D-0658-2016
Pharmedium Services, LLC · Lake Forest, IL
Class I — life-threatening Terminated 272 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.
Reason for recall
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Recall record
- Recall number
D-0658-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- WI
- Recall initiated
- 2015-05-22
- Classified by FDA Center
- 2016-02-10
- FDA published
- 2016-02-17
- Terminated
- 2016-02-18
- Recalling firm
- Pharmedium Services, LLC
- Firm location
- Lake Forest, IL