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
Reported: December 21, 2022 Initiated: December 6, 2022 #D-0094-2023
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
Reason for Recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Details
- Recalling Firm
- Camber Pharmaceuticals, Inc
- Units Affected
- N/A
- Distribution
- USA Nationwide
- Location
- Piscataway, NJ
Frequently Asked Questions
What product 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. Recalled by Camber Pharmaceuticals, Inc. Units affected: N/A.
Why was this product recalled? ▼
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 21, 2022. Severity: Low. Recall number: D-0094-2023.
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