Recalls / Class II
Class IID-0277-2019
Product
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.
- Brand name
- Childrens Allergy
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDC
- 56062-106
- FDA application
- ANDA201546
- Affected lot / code info
- Lot # 313345, Exp 12/18
Why it was recalled
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Publix Super Markets Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 8328 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-10-19
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-21
- Terminated
- 2020-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0277-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.