Drug 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.
D-0277-2019
Product summary
- Event
- Event 81483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8328 bottles
- Official record key
drug-enforcement:D-0277-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Code information: Lot # 313345, Exp 12/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications