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Recall Observatory FDA recall evidence

Drug product

NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ SKU 999855 NPX TRPL ANTIBIOTIC PLS PAIN OINMNT 1 OZ SKU 901498 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

D-1383-2022

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-1383-2022

Official wording

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

Code information: SKUs: 910320; 999855; 901498

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations