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.

Recall Insight

This FDA Drug action (record #D-0658-2016) was formally reported on February 17, 2016, with the manufacturer initiating the action on May 22, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Pharmedium Services, LLC is listed as the recalling firm, operating out of Lake Forest, IL. Federal records indicate 19 Syringes units are affected.

The documented reason for this recall is: Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. Distribution data in the federal record shows the product reached: WI. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.