The Recall Desk

Manufacturer

CutisPharma, Inc.

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-11-23

Of the 2 recalls from CutisPharma, 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-0138-2017·2016-11-23

    CutisPharma Recalls Omeprazole Kits Due to Labeling Error

    CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0139-2017·2016-11-23

    CutisPharma Recalls Omeprazole Compounding Kits Due to Labeling Error

    CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
    Category
    Drug
    Distribution
    Distributed nationwide