Home / Recalls / MACLEODS PHARMA USA, INC / D-0078-2022

D-0078-2022 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
135,082 Blister Packs/2,431,476 tablets

Product Description

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

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 #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024

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  • D-0835-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun (April 15, 2022)
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