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Recall Observatory FDA recall evidence

Drug product

REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

D-1456-2022

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-1456-2022

Official wording

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

Code information: SKUs: 917531; 900854; 999559; 998933

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations