May 2022 FDA Recall Drug by Ams Packaging Inc
D-1148-2022 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Ams Packaging Inc on May 10, 2022 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-1148-2022

Reason for Recall
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Initiated
05-10-2022
Reported
06-22-2022
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90152
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMS Packaging Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668

Batch or Lot Expiration Information

Lot# all lots