Drug recall D-0094-2023

Class III Terminated reported Dec 21, 2022

Product

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

Reason for recall

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

Lots and codes

Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024

Recall details

Recalling firm
Camber Pharmaceuticals, Inc, Piscataway, NJ
Quantity
N/A
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 6, 2022
Terminated
March 15, 2024

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