The Recall Desk

Manufacturer

Amedra Pharmaceuticals LLC

4 recalls in our database name Amedra Pharmaceuticals LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2014-01-01

Of the 4 recalls from Amedra Pharmaceuticals LLC 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

  • ModerateFDA (Drugs)·D-385-2014·2014-01-01

    Amedra Recalls Dexedrine Capsules Due to Dissolution Test Failures

    Amedra Pharmaceuticals is recalling 10,992 bottles of Dexedrine Spansules 15mg due to failed dissolution specifications at the 32-month stability level.

    Product
    Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-171-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-173-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-172-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
    Category
    Drug
    Distribution
    Distributed nationwide