Drug Enforcement D-0667-2024

CGMP deviations

Status

Ongoing

Classification

Class II

Report Date

October 2, 2024

Termination Date

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Product Information

Product description
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Product quantity
120 bottles
Reason for recall
CGMP deviations
Recall initiation reason
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Initial firm notification
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Distribution pattern
Product was sent to one distributor in North Carolina.

Location & Firm

Recalling firm
EnviroServe Chemicals Inc.
Address
603 S Wilson Ave

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

Recall number
D-0667-2024
Event ID
95390
Recall initiation date
September 18, 2024
Center classification date
September 24, 2024
Code info
Lot #: 042224-L1, Exp. Date 04/22/2025
More code info
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