FDA Drug Recalls

Recalls / Class III

Class IIID-0689-2021

Product

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

Affected lot / code info
Lot 14180

Why it was recalled

Failed Impurities/Degradation Specifications

Recalling firm

Firm
Teligent Pharma, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
105 Lincoln Avenue, N/A, Buena, New Jersey 08310

Distribution

Quantity
7872 tubes
Distribution pattern
Nationwide

Timeline

Recall initiated
2021-06-22
FDA classified
2021-07-19
Posted by FDA
2021-07-28
Terminated
2024-07-03
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0689-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.