The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0276-2019·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 12,432 bottles of Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL). The product is distributed by Meijer Distribution, Inc., in Grand Rapids, MI, and was sold nationwide in the USA. The specific lot number is 313342 with an expiration date of 12/18.

The recall was initiated because an unknown impurity was detected during routine stability testing that was higher than the specified limit. This is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their medicine cabinets for this specific product and lot number. If found, they should stop using the product and contact their pharmacist or Taro Pharmaceuticals for instructions on how to return or dispose of the medication.

The recalled product

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.
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Oral Solution
Hazard
Affected units
12,432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 313342
  • Exp 12/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Taro Pharmaceuticals U.S.A., Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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