Recalls / Class II
Class IID-0689-2022
Product
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.
- Affected lot / code info
- Batch: a) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501, 15523, Exp. 4/30/2022; 15812, Exp. 7/31/2022; 15972, 16034, 16037, Exp. 9/30/2022; 16105, 16143, Exp. 10/31/2022; 16539, 16746, 16747, Exp. 3/31/2023; 16906, Exp. 5/31/2023; 16962, 17041, Exp. 6/30/2023; 17110, Exp. 7/31/2023
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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
- 161,331 tubes
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-15
- FDA classified
- 2022-03-21
- Posted by FDA
- 2022-03-30
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0689-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.