Drug product
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
D-0715-2022
Product summary
- Event
- Event 89774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,468 containers
- Official record key
drug-enforcement:D-0715-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Code information: No lot number or expiration date.
Distribution pattern: Distributed in Arkansas USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations