Drug Enforcement D-0533-2025

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Status

Ongoing

Classification

Class II

Report Date

July 23, 2025

Termination Date

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Product Information

Product description
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Product quantity
N/A
Reason for recall
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Recall initiation reason
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Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Ascend Laboratories, LLC
Address
135 Us Highway 202 206 Ste 15, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0533-2025
Event ID
96770
Recall initiation date
July 9, 2025
Center classification date
July 17, 2025
Code info
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
More code info
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