Status
Completed
Drug Enforcement D-0092-2023
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Classification
Class II
Report Date
January 4, 2023
Termination Date
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Product Information
- Product description
- Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
- Product quantity
- 10,930 gallons
- Reason for recall
- CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide in United States and Canada.
Location & Firm
- Recalling firm
- NCH Life Sciences LLC
- Address
-
2730 Carl Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0092-2023
- Event ID
- 91272
- Recall initiation date
- December 9, 2022
- Center classification date
- December 28, 2022
- Code info
- Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
- More code info
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