Drug Enforcement D-0760-2023

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Status

Terminated

Classification

Class II

Report Date

May 31, 2023

Termination Date

July 1, 2024

Product Information

Product description
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
Product quantity
544 1 gallon bottles
Reason for recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Product was distributed to one account in NC.

Location & Firm

Recalling firm
Alpha Aromatics
Address
294 Alpha Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0760-2023
Event ID
92347
Recall initiation date
May 16, 2023
Center classification date
May 22, 2023
Code info
Lot: 2020-013211 and 2020-013629, No EXP date on label.
More code info
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