Drug product
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
D-0276-2019
Product summary
- Event
- Event 81483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,432 bottles
- Official record key
drug-enforcement:D-0276-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Code information: Lot # 313342, Exp 12/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications