D-0278-2022 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 22, 2021
- Initiation Date
- November 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 bottles
Product Description
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.
Distribution Pattern
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Code Information
Lot #: E1220B