D-0676-2022 Class II Terminated
FDA drug recall D-0676-2022 was initiated by Teligent Pharma, Inc. on March 15, 2022 and is designated Class II. Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. The recall status is terminated (terminated June 17, 2024). Affected quantity: 6850 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2022
- Initiation Date
- March 15, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6850 tubes
Product Description
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
Reason for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Batch: 15996, 15997, Exp. 9/30/2022