PlainRecalls
FDA Drug Low Class III Terminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

Reported: May 5, 2021 Initiated: February 2, 2021 #D-0340-2021

Product Description

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

Reason for Recall

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
N/A
Distribution
USA Nationwide
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15. Recalled by Teligent Pharma, Inc.. Units affected: N/A.
Why was this product recalled?
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 5, 2021. Severity: Low. Recall number: D-0340-2021.