April 2016 FDA Recall Sensorcaine by Fresenius Kabi Usa, Llc
D-1037-2016 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on April 25, 2016 for the product Sensorcaine. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1037-2016
Presence of Particulate Matter: Glass particulate found in sterile injectable product
04-25-2016
06-22-2016
69225 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-20-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Batch or Lot Expiration Information
Lot# : 6111504, Exp 09/2019
