FDA Recall D-0382-2024
Optikem International, Inc. · Denver, CO
Class II Ongoing 805 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0382-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product distributed Nationwide in the USA
- Recall initiated
- 2024-02-29
- Classified by FDA Center
- 2024-03-12
- FDA published
- 2024-03-20
- Recalling firm
- Optikem International, Inc.
- Firm location
- Denver, CO
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.