Home / Recalls / Macleods Pharma Usa Inc / D-1844-2019

D-1844-2019 Class II Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
August 21, 2019
Initiation Date
July 17, 2019
Termination Date
February 9, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 5448 bottles b) 972 bottles c) 158 bottles

Product Description

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

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

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

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