Reported Dec 9, 2015 · Terminated
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…
Geritrex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Geritrex Corp · 144 Kingsbridge Road East · Mount Vernon, NY · 10550
Is this the product you have?
- 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 byGeritrex Corporation, Mount Vernon, NY 10550
- Lot codes and dates
Lot #: a) 12010921403053121002810070591112105130504413030791406098140706115050371412004 1408081b) 1112105 & 1007036
- Amount recalled
- 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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