October 2017 FDA Recall Drug by Ace Surgical Supply Co., Inc.
D-0071-2018 - Labeling
This Class II drug recall was voluntarily initiated by Ace Surgical Supply Co., Inc. on October 24, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.
Recall Number: D-0071-2018
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
10-24-2017
11-15-2017
200 vials (25 mislabeled vials)
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.
Ace Surgical Supply Co., Inc.
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.
Product was distributed throughout the United States.
03-20-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Batch or Lot Expiration Information
Lot# 64340EV, exp 07/2018 ACE ITEM # 1671018
