FDAClass IIINovember 3, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg recall: Impurity Out of Spec

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods…

Why was Rizatriptan Benzoate Orally Disintegrating Tablets 10mg recalled?

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

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 #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025

Product
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods…
Recalling firm
MACLEODS PHARMA USA, INC
Quantity
643,800 Blister Packs /888,336 Tablets
Distribution
Nationwide within the United States
Recall date
November 3, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls