Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-0
Summary
The FDA issued a Class II for Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, I by Teligent Pharma, Inc.. Reason: Correct Labeled Product Mispack.
Details
Source
Drug Recall
External ID
D-0751-2021
Action Date
2021-08-25
Status
Terminated
Category
drug
Product Description
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Lot/Code Info: Lot # 16630; Exp 03/2023
Quantity Affected: 14688 tubes
Reason for Recall
Correct Labeled Product Mispack
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-19
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 55 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-0751-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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