D-0716-2022 Class II Terminated
FDA drug recall D-0716-2022 was initiated by Teligent Pharma, Inc. on Feb 7, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds. The recall status is terminated (terminated May 9, 2024). Affected quantity: 11040 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 23, 2022
- Initiation Date
- Feb 7, 2022
- Termination Date
- May 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11040 tubes
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 15724, Exp. 06/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0716-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026