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Recall Observatory FDA recall evidence

Drug product

READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999747 READY IN CASE 91PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999742 READY IN CASE 70PCT ISOPROPYL ALCOHOL 16 FL OZ SKU 999743 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

D-1422-2022

June 23, 2022

Class II

Product summary

Firm
Family Dollar Stores, Llc.
Event
Event 90566
Status
Ongoing
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-1422-2022

Official wording

Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

Code information: SKUs: 902270; 999747; 999742; 999743

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations