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Recall Observatory FDA recall evidence

Drug product

Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10

D-0627-2022

October 26, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88905
Status
Terminated
Classification
Class II
Quantity
79,776 botles
Official record key
drug-enforcement:D-0627-2022

Official wording

Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information: Batch: 1BK0931, Exp 12/31/2022; 1CK0900, Exp 01/31/2023; 1HK1196, Exp 02/28/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations