FDA Recall D-0521-2023
Preferred Pharmaceuticals, Inc. · Anaheim, CA
Class II Ongoing 1148 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Reason for recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall record
- Recall number
D-0521-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2023-03-23
- Classified by FDA Center
- 2023-04-06
- FDA published
- 2023-04-12
- 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.