Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Ro
Summary
The FDA issued a Class II for Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufact by Teligent Pharma, Inc.. Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program..
Details
Source
Drug Recall
External ID
D-0703-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
Lot/Code Info: Batch: 16896, 16897 Exp. 5/31/2023
Quantity Affected: 6874 bottles
Reason for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-15
Company
Buena, NJ
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 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teligent Pharma, Inc. has 53 FDA actions in our database, including 53 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 (Teligent Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teligent Pharma, Inc. have FDA actions?
Teligent Pharma, Inc. has 53 FDA actions in our database, including 53 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0703-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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