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.
Reported: November 21, 2018 Initiated: October 19, 2018 #D-0277-2019
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Details
- Recalling Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Units Affected
- 8328 bottles
- Distribution
- Nationwide in the USA
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 8328 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Moderate. Recall number: D-0277-2019.
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