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Recall Observatory FDA recall evidence

Drug product

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858,

D-0837-2021

July 14, 2021

Class II

Product summary

Firm
Johnson & Johnson Consumer, Inc.
Event
Event 88288
Status
Ongoing
Classification
Class II
Quantity
a) 5oz-1,282,488; b) 8oz-475,476 cans
Official record key
drug-enforcement:D-0837-2021

Official wording

Reason: cGMP Deviations

Code information: All lots within expiry.

Distribution pattern: Nationwide in US

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations