Recalls / Class II
Class IID-0670-2022
Product
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
- Affected lot / code info
- Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp. 7/31/2022; 16237, Exp. 11/30/2022; 16388, Exp. 2/28/2023; d) 15605, Exp. 7/31/2022; 15860, Exp. 8/31/2022; 16001, Exp. 9/30/2022; 16237, Exp. 11/30/2022; 16344, Exp. 1/31/2023; 16294, Exp. 2/28/2023; 16474, Exp. 2/28/2023; 16543, Exp. 2/28/2023.
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
- 207,933 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-0670-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.