Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals
Summary
The FDA issued a Class III for Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, by Camber Pharmaceuticals, Inc. Reason: Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content.
Details
Source
Drug Recall
External ID
D-0094-2023
Action Date
2022-12-21
Status
Terminated
Category
drug
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
Lot/Code Info: Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Quantity Affected: N/A
Reason for Recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-06
Company
Piscataway, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Camber Pharmaceuticals, Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Camber Pharmaceuticals, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Camber Pharmaceuticals, Inc have FDA actions?
Camber Pharmaceuticals, Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0094-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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