FDA recall D-0716-2022

Product

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

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-02-07

Report date

2022-02-23

Termination date

2024-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0716-2022