Why it was recalled
CGMP Deviations: Does not meet monograph for denaturant.
Product description
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
Lot numbers, UPCs & expiration codes
All distributed lots within expiry
Where it was sold
Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
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-0698-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2021
- FDA report date
- Aug 11, 2021
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cascade Kelly Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0698-2021, exactly as published.
Show all FDA fields
- City
- Clatskanie
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 88222
- Address
- 81200 Kallunki Rd
- Code information
- All distributed lots within expiry
- Postal code
- 97016-2244
- Report date
- Aug 11, 2021
- Product type
- Drugs
- Recall number
- D-0698-2021
- Classification
- Class II
- Recalling firm
- Cascade Kelly Holdings LLC
- Termination date
- Jul 20, 2022
- Reason for recall
- CGMP Deviations: Does not meet monograph for denaturant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
- Distribution pattern
- Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
- Recall initiation date
- Jun 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2021