Food, drugs, devices › Camber Pharmaceuticals, Inc
Drug recall: Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals
FDA enforcement event 91239 is a drug recall by Camber Pharmaceuticals, Inc of Piscataway, NJ, initiated 6 Dec 2022 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 15 Mar 2024. Initiation: voluntary: firm initiated. Camber Pharmaceuticals, Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Camber Pharmaceuticals, Inc, Piscataway, NJ.
Reason for recall
"Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content"
Distribution
"USA Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0094-2023 | 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 | N/A | Class III | Terminated | 21 Dec 2022 |
Context
Other enforcement events for Camber Pharmaceuticals, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Mar 2023 | Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., | Drug | Class I | 1 |
| 28 Feb 2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1 | Drug | Class II | 3 |
All 3 events for Camber Pharmaceuticals, Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "USA Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Mar 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.