September 2017 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-0053-2018 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on September 5, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed in Florida and the recall is currently terminated.
Recall Number: D-0053-2018
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
09-05-2017
11-01-2017
12 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Aidarex Pharmaceuticals 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed in Florida
12-01-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Batch or Lot Expiration Information
Lot# : 55097-2, 56085-1, Exp 11/30/2018
