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Recall Observatory FDA recall evidence

Drug product

BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

D-1391-2022

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-1391-2022

Official wording

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

Code information: SKUs: 901588; 913228; 901589

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations