Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12

Recall Insight

This FDA Drug action (record #D-0156-2018) was formally reported on January 17, 2018, with the manufacturer initiating the action on December 7, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. SCA Pharmaceuticals is listed as the recalling firm, operating out of Little Rock, AR. Federal records indicate 1248 syringes units are affected.

The documented reason for this recall is: Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. Distribution data in the federal record shows the product reached: U.S.A. Nationwide. 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 8 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.