Recalls / Class II
Class IID-0692-2022
Product
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
- Affected lot / code info
- Batch: a) 16293, Exp. 1/31/2023; 16436, 16451, Exp. 2/28/2023; b) 15105, Exp. 2/28/2022; 15290, 15291, 15292, Exp. 3/31/2022; 16293, Exp. 1/31/2023; 16436, 16451, 16472, 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
- 30,497 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-0692-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.