Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Summary
The FDA issued a Class III for Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Bu by Teligent Pharma, Inc.. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0689-2021
Action Date
2021-07-28
Status
Terminated
Category
drug
Product Description
Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Lot/Code Info: Lot 14180
Quantity Affected: 7872 tubes
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-22
Company
Buena, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 49 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0689-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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