Drug recall D-0079-2022

Class III Terminated reported Nov 3, 2021

Product

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 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 33342-093-41

Reason for recall

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

Lots and codes

Lot #: BRL2102A, BRL2103A, exp. date 04/2025

Recall details

Recalling firm
MACLEODS PHARMA USA, INC, Princeton, NJ
Quantity
13,260 Blister Packs/238,680 tablets
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
October 18, 2021
Terminated
April 24, 2024

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