Skip to content
Recall Observatory FDA recall evidence

Drug product

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10

D-0612-2022

October 26, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88905
Status
Terminated
Classification
Class II
Quantity
19,584 bottles
Official record key
drug-enforcement:D-0612-2022

Official wording

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

Code information: Batch: 1BK0716, Exp 12/31/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations