Clobetasol Propionate Cream USP recall: CGMP Deviations
Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
Why was Clobetasol Propionate Cream USP recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch: 16001 Exp. 9/30/2022; 16089 Exp. 11/30/2022
- Product
- Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
- Recalling firm
- Teligent Pharma, Inc.
- Quantity
- 26,326 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- March 30, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)