FDA Recall D-0646-2022

AMS Packaging Inc · South Plainfield, NJ

Class II Ongoing 1567 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.

Lot / code: All lots within expiry and labelled as 'Made in the USA'

Quantity: 2,095,567 bottles

Reason for recall

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

Recall record

Recall number: D-0646-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2022-01-28
Classified by FDA Center: 2022-03-07
FDA published: 2022-03-02
Recalling firm: AMS Packaging Inc
Firm location: South Plainfield, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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