FDA Recall D-1148-2022
AMS Packaging Inc · South Plainfield, NJ
Class II Ongoing 1465 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%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
Reason for recall
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Recall record
- Recall number
D-1148-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Recall initiated
- 2022-05-10
- Classified by FDA Center
- 2022-06-14
- FDA published
- 2022-06-22
- 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.