FDAClass IIFebruary 17, 2016

Pramipexole Dihydrochloride Tablets 0.125 mg recall

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured…

Why was Pramipexole Dihydrochloride Tablets 0.125 mg recalled?

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

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?

Lot #: BPA512A; Expiry: 06/2017.

Product
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured…
Recalling firm
Macleods Pharma Usa Inc
Quantity
N/A
Distribution
US Nationwide.
Recall date
February 17, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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