July 2019 FDA Recall Tamsulosin Hydrochloride by Macleods Pharma Usa Inc
D-1844-2019 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on July 17, 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-1844-2019

Reason for Recall
Failed Dissolution Specifications
Initiated
07-17-2019
Reported
08-21-2019
Quantity
a) 5448 bottles b) 972 bottles c) 158 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83414
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Macleods Pharma Usa Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2021
Product Description About Product Description
Full technical description of the product.
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA

Batch or Lot Expiration Information

Lot# a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020

Affected Packages Involved in this Recall

33342-159-07 Tamsulosin Hydrochloride
33342-159-11 Tamsulosin Hydrochloride
33342-159-44 Tamsulosin Hydrochloride
33342-159-12 Tamsulosin Hydrochloride
33342-159-15 Tamsulosin Hydrochloride