Recalls / Class II
Class IID-0678-2022
Product
Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
- Affected lot / code info
- Batch: a) 15496, Exp. 4/30/2022; 16347, Exp. 1/31/2023; b) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023; c) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023
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
- 13,989 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-0678-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.