Proctofoam HC recall: CGMP Deviations
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.
Why was Proctofoam HC recalled?
cGMP deficiencies
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?
Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
- Product
- Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.
- Recalling firm
- Mylan Pharmaceuticals Inc
- Quantity
- 233,199/10 g aerosol containers
- Distribution
- Recalled product was distributed nationwide within the United States.
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)