Why it was recalled
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Product description
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Lot numbers, UPCs & expiration codes
Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
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-0164-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 17, 2023
- FDA report date
- Jan 25, 2023
- Quantity
- 106 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fisher Scientific Co., LLC
Original FDA data
Every field from FDA enforcement report D-0164-2023, exactly as published.
Show all FDA fields
- City
- Fair Lawn
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91427
- Address
- 1 Reagent Ln
- Code information
- Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
- Postal code
- 07410-2802
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0164-2023
- Classification
- Class II
- Recalling firm
- Fisher Scientific Co., LLC
- Product quantity
- 106 bottles
- Reason for recall
- CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 17, 2023
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 18, 2023