Drug product
QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1450-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1450-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 900449; 916003; 916918; 901738; 916917; 999834; 902217; 916715
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations