Recalls / Class II
Class IID-0698-2022
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
- Affected lot / code info
- Batch: 14796, Exp. 12/31/2022; 14797, Exp. 1/31/2023; 14534, 15571, 15572, Exp. 4/30/2023; 15746, 15756, Exp. 6/30/2023; 15982, Exp. 9/30/2023; 16043, 16144, 16149, Exp. 10/31/2023; 16433, 16434, Exp. 2/29/2024; 16656, 16679, Exp. 3/31/2024; 16784, Exp. 5/31/2024
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
- 112,769 bottles
- 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-0698-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.