Polyethylene Glycol 3350-GRX Powder 100% jars a) recall
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
Why was Polyethylene Glycol 3350-GRX Powder 100% jars a) 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) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036
- Product
- 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
- Recalling firm
- Geritrex Corp
- Quantity
- 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
- Distribution
- Nationwide
- Recall date
- December 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)