FDA Drug recall D-0094-2023
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,…
- FDA Drug
- Class III
- terminated
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class III recall of Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,… by Camber Pharmaceuticals, citing failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0094-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-12-06 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Camber Pharmaceuticals |
| Distribution | US |
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
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Identifiers
| ndc | 31722-627-26 |
|---|---|
| ndc | 31722-627-46 |
| code_info | Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Camber Pharmaceuticals
- Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 0885…
FDA Drug · Class I · 2023-05-17 · Camber Pharmaceuticals - Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-7…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals - Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 3172…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals - Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-70…
FDA Drug · Class II · 2019-03-27 · Camber Pharmaceuticals
All Camber Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0094-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.