FDA Recall D-0667-2024
EnviroServe Chemicals Inc. · Dunn, NC
Class II Ongoing 603 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Reason for recall
CGMP deviations
Recall record
- Recall number
D-0667-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Product was sent to one distributor in North Carolina.
- Recall initiated
- 2024-09-18
- Classified by FDA Center
- 2024-09-24
- FDA published
- 2024-10-02
- Recalling firm
- EnviroServe Chemicals Inc.
- Firm location
- Dunn, NC
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.