PlainRecalls
FDA Drug Moderate Class II Terminated

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Reported: March 30, 2022 Initiated: March 15, 2022 #D-0672-2022

Product Description

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Reason for Recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
35,180 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.. Recalled by Teligent Pharma, Inc.. Units affected: 35,180 bottles.
Why was this product recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0672-2022.