Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Reported: March 30, 2022 Initiated: March 15, 2022 #D-0689-2022
Product Description
Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 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
- 161,331 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Buena, NJ
Frequently Asked Questions
What product was recalled? ▼
Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.. Recalled by Teligent Pharma, Inc.. Units affected: 161,331 tubes.
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-0689-2022.
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