Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Di
Summary
The FDA issued a Class II for Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Te by Teligent Pharma, Inc.. Reason: Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds..
Details
Source
Drug Recall
External ID
D-0716-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
Lot/Code Info: Lot: 15724, Exp. 06/2022
Quantity Affected: 11040 tubes
Reason for Recall
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-07
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 60 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-0716-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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