Home / Recalls / MACLEODS PHARMA USA, INC / D-0080-2022

D-0080-2022 Class III Terminated

Recalled by MACLEODS PHARMA USA, INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
November 3, 2021
Initiation Date
October 18, 2021
Termination Date
April 24, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
643,800 Blister Packs /888,336 Tablets

Product Description

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

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

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