August 2018 FDA Recall Drug by Akorn, Inc.
D-1046-2018 - Failed Impurities/Degredation Specifications
This Class II drug recall was voluntarily initiated by Akorn, Inc. on August 1, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degredation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1046-2018
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
08-01-2018
08-15-2018
22,605 tubes
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.
Akorn, 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.
Nationwide within the USA
11-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Batch or Lot Expiration Information
Lot# : 356309, Exp. 3/2019
