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
Reported: December 9, 2015 Initiated: October 27, 2015 #D-0390-2016
Product Description
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
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Details
- Recalling Firm
- Geritrex Corp
- Units Affected
- 9,948 tubes: 3 oz(8,832), 7 oz(1,116)
- Distribution
- Nationwide
- Location
- Mount Vernon, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Geritrex Corp. Units affected: 9,948 tubes: 3 oz(8,832), 7 oz(1,116).
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2015. Severity: Moderate. Recall number: D-0390-2016.
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