FDAClass IIISeptember 18, 2019

Pramipexole Dihydrochloride Tablets 0.125 mg recall: Subpotent

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

Why was Pramipexole Dihydrochloride Tablets 0.125 mg recalled?

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

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 #BPA801A, EXP 12/2020

Product
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured…
Recalling firm
Macleods Pharma Usa Inc
Quantity
1837 90-count bottles
Distribution
Distributed Nationwide in the USA
Recall date
September 18, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls