Recalls / Class II
Class IID-0278-2022
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
- Affected lot / code info
- Lot #: E1220B
Why it was recalled
Defective container: Out of specification for container integrity leading to bottles leaking.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 72 bottles
- Distribution pattern
- Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Timeline
- Recall initiated
- 2021-11-29
- FDA classified
- 2021-12-13
- Posted by FDA
- 2021-12-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0278-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.