The Recall Desk

Manufacturer

Amerigen Pharmaceuticals Inc.

4 recalls in our database name Amerigen Pharmaceuticals Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2019-02-27

Of the 4 recalls from Amerigen Pharmaceuticals Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • LowFDA (Drugs)·D-0516-2019·2019-02-27

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0344-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0345-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

    Product
    Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0249-2019·2018-10-24

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide capsules because stability testing revealed out-of-specification dissolution results.

    Product
    Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
    Category
    Drug
    Distribution
    Distributed nationwide