Food, drugs, devices › Amerigen Pharmaceuticals Inc.
Drug recall: Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx
FDA enforcement event 82158 is a drug recall by Amerigen Pharmaceuticals Inc. of Lyndhurst, NJ, initiated 19 Feb 2019 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. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 17 Dec 2019. Initiation: voluntary: firm initiated. Amerigen 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
Amerigen Pharmaceuticals Inc., Lyndhurst, NJ.
Reason for recall
"Failed dissolution specifications"
Distribution
"Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0516-2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071 | a) 2,413 bottles b) 3,355 bottles | Class III | Terminated | 27 Feb 2019 |
Context
Other enforcement events for Amerigen Pharmaceuticals Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Dec 2018 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx | Drug | Class III | 2 |
| 5 Oct 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx | Drug | Class III | 1 |
All 3 events for Amerigen Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed dissolution specifications"
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: "Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Dec 2019. "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.