FDAFDA · Food and drugs·Recall number D-0278-2019
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.
Published November 21, 2018 · Recall initiated: October 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # 313344, Exp 12/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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