FDA Recall D-0770-2021
HIS ENTERPRISE INC · Palisades Park, NJ
Class II Ongoing 1759 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Reason for recall
Marketed without ANDA/NDA approval
Recall record
- Recall number
D-0770-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- USA nationwide.
- Recall initiated
- 2021-07-20
- Classified by FDA Center
- 2021-08-26
- FDA published
- 2021-09-01
- Recalling firm
- HIS ENTERPRISE INC
- Firm location
- Palisades Park, NJ
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.