Recalls / Class II
Class IID-0278-2019
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.
- Affected lot / code info
- Lot # 313344, 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.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- 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-0278-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.