FDA Recall D-0278-2022
Preferred Pharmaceuticals, Inc. · Anaheim, CA
Class II Ongoing 1627 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Reason for recall
Defective container: Out of specification for container integrity leading to bottles leaking.
Recall record
- Recall number
D-0278-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
- Recall initiated
- 2021-11-29
- Classified by FDA Center
- 2021-12-13
- FDA published
- 2021-12-22
- 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.