The Recall Desk

FDA (Drugs) recall action 61891

Noven Pharmaceuticals, Inc. recalled 4 products on 2012-06-20

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2012-06-20
Critical
0
Units
1,179,120

Why these products were recalled

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2012-06-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 244,320 Daytrana patches because the delivery system is miscalibrated or defective, making it difficult to remove the release liner.

    Product
    Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc.,
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-06-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 357,510 Daytrana (methylphenidate) patches because the delivery system may be miscalibrated or defective, affecting the ability to remove the release liner.

    Product
    DAYTRANA (METHYLPHENIDATE)
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-06-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 335,190 Daytrana patches because the delivery system may be miscalibrated or defective, affecting the ability to remove the release liner.

    Product
    Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc.,
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-06-20

    Daytrana Transdermal Patch Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana transdermal patches because the release liner may be difficult to remove. This could affect the patient's ability to apply the medication correctly.

    Product
    Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Mi
    Category
    Distribution
    1 state