Why it was recalled
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Product description
ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202
Lot numbers, UPCs & expiration codes
No lot number or expiration date.
Where it was sold
Distributed in Arkansas 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-0715-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 35,468 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rock Town Distillery, Inc.
Original FDA data
Every field from FDA enforcement report D-0715-2022, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 89774
- Address
- 1201 Main St
- Code information
- No lot number or expiration date.
- Postal code
- 72202-5031
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0715-2022
- Classification
- Class II
- Recalling firm
- Rock Town Distillery, Inc.
- Product quantity
- 35,468 containers
- Termination date
- Aug 23, 2023
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202
- Distribution pattern
- Distributed in Arkansas USA
- Recall initiation date
- Mar 10, 2022
- Initial firm notification
- Other
- Center classification date
- Mar 23, 2022