The Recall Desk

FDA (Drugs) recall action 81483

Taro Pharmaceuticals U.S.A., Inc. recalled 3 products on 2018-11-21

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2018-11-21
Critical
0
Units
20,760

Why these products were recalled

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

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.

1–3 of 3

  • ModerateFDA (Drugs)··2018-11-21

    Taro Recalls Children's Allergy Relief Oral Solution Due to Impurity

    Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.

    Product
    children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-21

    Taro Recalls Children's Allergy Solution Due to Impurity

    Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.

    Product
    Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-11-21

    Taro Recalls Children's Allergy Oral Solution Due to Impurity

    Taro Pharmaceuticals is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) oral solution because an unknown impurity exceeded specified limits during stability testing.

    Product
    CHILDRENS ALLERGY (CETIRIZINE HYDROCHLORIDE)
    Category
    Distribution
    0 states