Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Phar...
FDA Recall #D-0278-2022 — Class II — November 29, 2021
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.
Recalling Firm
Preferred Pharmaceuticals, Inc. — Anaheim, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
72 bottles
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Code Information
Lot #: E1220B
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated