February 2019 FDA Recall Tamsulosin Hydrochloride by Ascend Laboratories Llc
D-1066-2019 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on February 22, 2019 for the product Tamsulosin Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1066-2019
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
02-22-2019
03-13-2019
3,072 bottles
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.
Ascend Laboratories 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 in the USA and Puerto Rico.
03-18-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.
Batch or Lot Expiration Information
Lot# : 8144652, Exp Jul 2020
