Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Pre
Summary
The FDA issued a Class II for Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle by Preferred Pharmaceuticals, Inc.. Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability st.
Details
Source
Drug Recall
External ID
D-0773-2022
Action Date
2022-04-27
Status
Terminated
Category
drug
Product Description
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
Lot/Code Info: Lots: E1220B, Exp.: 01/31/2023; F0220M, Exp.: 3/31/2023; F2320A, Exp.: 3/31/2023; F3020M, Exp.: 3/31/2023; G0920Q, Exp.: 3/31/2023; C0821M, Exp.: 1/31/2024; J1920, Exp.: 5/31/2023; E2421j, Exp.: 4/30/2024
Quantity Affected: 528 bottles
Reason for Recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Distribution
Nationwide within the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-24
Company
Anaheim, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preferred Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0773-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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