Drug product
CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1451-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1451-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 900834; 916116; 916114; 901655
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations