The Recall Desk

Manufacturer

Mayne Pharma Usa

1 recall in our database name Mayne Pharma Usa as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2016-01-27

Of the 1 recalls from Mayne Pharma Usa we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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.

1–1 of 1

  • SevereFDA (Drugs)·D-0585-2016·2016-01-27

    Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure

    Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
    Category
    Drug
    Distribution
    Distributed nationwide