Drug Enforcement D-0925-2023

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

July 26, 2023

Termination Date

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Product Information

Product description
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Product quantity
2652 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Ascend Laboratories, LLC
Address
339 Jefferson Rd Ste 101, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0925-2023
Event ID
92667
Recall initiation date
July 11, 2023
Center classification date
July 18, 2023
Code info
Lot 22122841, Exp August 2025
More code info
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