PlainRecalls
FDA Drug Low Class III Terminated

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

Reported: June 26, 2019 Initiated: May 20, 2019 #D-1391-2019

Product Description

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
9360 tubes
Distribution
Nationwide
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310. Recalled by Teligent Pharma, Inc.. Units affected: 9360 tubes.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on June 26, 2019. Severity: Low. Recall number: D-1391-2019.