PAJUNK Epidural Tray (Pajunk) – Medication Labeling Error (2022)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

Recommended Action

Per FDA guidance

The recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022. The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible. A return label was enclosed for return of product. A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned. The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride. If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.