Recalls / Class II
Class IID-0674-2022
Product
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
- Affected lot / code info
- Batch: a) 15063, Exp. 2/28/2022; 15928, Exp. 9/30/2022; 16432, Exp. 2/28/2023; 16769, Exp. 4/30/2023; b) 15243, Exp. 2/28/2022; 16628, Exp. 3/31/2023; c) 15064, 15286, 15287, Exp. 2/28/2022; 16173, Exp. 11/30/2022; 16628, Exp. 3/31/2023
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
- 81,883 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-0674-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.