FDA Recall D-0505-2024
Preferred Pharmaceuticals, Inc. · Anaheim, CA
Class II Ongoing 734 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall record
- Recall number
D-0505-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product distributed to CA, FL, OK, KS and CT
- Recall initiated
- 2024-05-10
- Classified by FDA Center
- 2024-05-21
- FDA published
- 2024-05-29
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Firm location
- Anaheim, CA
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.