Drug Enforcement D-0094-2023

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

Status

Terminated

Classification

Class III

Report Date

December 21, 2022

Termination Date

March 15, 2024

Product Information

Product description
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
Product quantity
N/A
Reason for recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Camber Pharmaceuticals, Inc
Address
1031 Centennial Ave, N/A

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

Codes & Dates

Recall number
D-0094-2023
Event ID
91239
Recall initiation date
December 6, 2022
Center classification date
December 28, 2022
Code info
Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
More code info
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