Drug Enforcement D-0298-2025

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Status

Ongoing

Classification

Class II

Report Date

April 2, 2025

Termination Date

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Product Information

Product description
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Product quantity
57,184 bottles
Reason for recall
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Johnson, S C and Son, Inc
Address
1525 Howe St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0298-2025
Event ID
96334
Recall initiation date
January 8, 2025
Center classification date
March 25, 2025
Code info
Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
More code info
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