Drug Enforcement D-0339-2024

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Status

Ongoing

Classification

Class II

Report Date

February 28, 2024

Termination Date

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Product Information

Product description
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Product quantity
71,244 sachets
Reason for recall
Failed Impurities/Degradation Specification: Out of specification for organic impurities
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-0339-2024
Event ID
93816
Recall initiation date
January 16, 2024
Center classification date
February 20, 2024
Code info
lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
More code info
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