Clobetasol Propionate Cream USP recall: CGMP Deviations
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
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: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp. 7/31/2022; 16237, Exp. 11/30/2022; 16388, Exp. 2/28/2023; d) 15605, Exp. 7/31/2022; 15860, Exp. 8/31/2022; 16001, Exp. 9/30/2022; 16237, Exp. 11/30/2022; 16344, Exp. 1/31/2023; 16294, Exp. 2/28/2023; 16474, Exp. 2/28/2023; 16543, Exp. 2/28/2023.
- Product
- Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
- Recalling firm
- Teligent Pharma, Inc.
- Quantity
- 207,933 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- March 30, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)