Drug 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.
D-0278-2019
Product summary
- Event
- Event 81483
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0278-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Code information: Lot # 313344, Exp 12/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications