Drug & medication recalls

Camber Pharmaceuticals, Inc recalls Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceutical…

Recall date
December 6, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0094-2023
FDA classification
Class III
Brand / firm
Camber Pharmaceuticals, Inc
Sold / distributed
USA Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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