D-0689-2021 Class III Terminated

Recalled by Teligent Pharma, Inc. — Buena, NJ

FDA drug recall D-0689-2021 was initiated by Teligent Pharma, Inc. on June 22, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated July 3, 2024). Affected quantity: 7872 tubes.

Recall Details

Product Type
Drugs
Report Date
July 28, 2021
Initiation Date
June 22, 2021
Termination Date
July 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7872 tubes

Product Description

Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide

Code Information

Lot 14180