The Recall Desk

FDA (Drugs) recall action 75982

Gentell, Inc recalled 2 products on 2017-01-11

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-01-11
Critical
0
Units
3,000

Why these products were recalled

CGMP Deviations

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.

1–2 of 2

  • ModerateFDA (Drugs)··2017-01-11

    Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-01-11

    Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
    Category
    Distribution
    0 states