Carbo-O-Philic 40 Cream 40% recall
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Why was Carbo-O-Philic 40 Cream 40% recalled?
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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 #: a)1502156, 1507104 b)1503039, 1507001
- Product
- Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
- Recalling firm
- Geritrex Corp
- Quantity
- 9,948 tubes: 3 oz(8,832), 7 oz(1,116)
- Distribution
- Nationwide
- Recall date
- December 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)