October 2016 FDA Recall Drug by Pharmedium Services, Llc
D-0125-2017 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on October 12, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0125-2017
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
10-12-2016
11-09-2016
1550 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.
Pharmedium Services, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
11-08-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Batch or Lot Expiration Information
Lot# : 162790012M, Exp. 1/3/2017
