The Recall Desk

Manufacturer

Roxane Laboratories, Inc.

2 recalls in our database name Roxane Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2017-02-01

Of the 2 recalls from Roxane Laboratories, 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.

1–2 of 2

  • LowFDA (Drugs)·D-0448-2017·2017-02-01

    Roxane Recalls Azelastine Nasal Spray Due to Defective Delivery System

    Roxane Laboratories is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Spray because the delivery system failed droplet size testing.

    Product
    Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
    Category
    Drug
    Distribution
    Distributed nationwide