Drug Enforcement D-1145-2023

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Status

Ongoing

Classification

Class III

Report Date

September 13, 2023

Termination Date

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Product Information

Product description
Fosfomycin Tromethamine Granules for Oral Solution, 3 g 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
99,516 sachets
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
The recall product was distributed nationwide.

Location & Firm

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

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

Recall number
D-1145-2023
Event ID
92706
Recall initiation date
July 18, 2023
Center classification date
September 6, 2023
Code info
Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
More code info
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