FDA Recall D-0647-2024
Preferred Pharmaceuticals, Inc. · Anaheim, CA
Class II Ongoing 644 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Reason for recall
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Recall record
- Recall number
D-0647-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- CA and NV
- Recall initiated
- 2024-08-08
- Classified by FDA Center
- 2024-08-26
- FDA published
- 2024-09-04
- 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.