Camber Pharmaceuticals, Inc: Drug Recall

Recall #D-0094-2023 · 12/06/2022

Class III: Low Risk

Recall Details

Recall Number: D-0094-2023
Classification: Class III
Product Type: Drug
Recalling Firm: Camber Pharmaceuticals, Inc
Status: Terminated
Date Initiated: 12/06/2022
Location: Piscataway, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

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

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

Distribution Pattern

USA Nationwide

Other Recalls by Camber Pharmaceuticals, Inc

Class I: Dangerous 03/13/2023

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

View all recalls by Camber Pharmaceuticals, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.