Key Takeaway
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, by Taro Pharmaceuticals U.S.A., Inc. was recalled on October 19, 2018. The hazard: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
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,
Description
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.
Hazard / Reason
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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,
DrugsCompany Information
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY, United States
View all 36 recalls by Taro Pharmaceuticals U.S.A., Inc. →Distribution
Nationwide in the USA
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.