Multi event Drug Recall Enforcement Report Class II voluntary initiated by Taro Pharmaceuticals U.S.A., Inc., originally initiated on 10-19-2018 for the product 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. The product was recalled due to failed impurities/degradation specifications: unknown impurity higher than the specified limit was detected during routine stability testing.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0278-2019 | 10-19-2018 | 11-21-2018 | Class II | | 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. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Terminated |
| D-0276-2019 | 10-19-2018 | 11-21-2018 | Class II | 12,432 bottles | 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. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Terminated |
| D-0277-2019 | 10-19-2018 | 11-21-2018 | Class II | 8328 bottles | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 56062-106 | Childrens Allergy | Cetirizine Hydrochloride | Solution | Oral | Publix Super Markets Inc | Human Otc Drug |
