Why it was recalled
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Product description
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1148-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 10, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMS Packaging Inc
Original FDA data
Every field from FDA enforcement report D-1148-2022, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 90152
- Address
- 161 Helen St
- Code information
- all lots
- Postal code
- 07080-3806
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1148-2022
- Classification
- Class II
- Recalling firm
- AMS Packaging Inc
- Product quantity
- unknown
- Reason for recall
- Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 10, 2022
- Center classification date
- Jun 14, 2022