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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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