FDAClass IIAugust 21, 2019

Tamsulosin Hydrochloride Capsules recall: Failed Dissolution

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…

Why was Tamsulosin Hydrochloride Capsules recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Macleods Pharma Usa Inc
Quantity
a) 5448 bottles b) 972 bottles c) 158 bottles
Distribution
Nationwide
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls