Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
Reported: December 9, 2015 Initiated: October 27, 2015 #D-0393-2016
Product Description
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, 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
- 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
- Distribution
- Nationwide
- Location
- Mount Vernon, NY
Frequently Asked Questions
What product was recalled? ▼
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550. Recalled by Geritrex Corp. Units affected: 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350.
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-0393-2016.
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