Children's 24 Hour Allergy recall: Impurity Out of Spec
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…
Why was Children's 24 Hour Allergy recalled?
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 313342, Exp 12/18
- 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…
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Quantity
- 12,432 bottles
- Distribution
- Nationwide in the USA
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)