Class II
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 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
- Company
- Geritrex Corp
- Recall Initiated
- October 27, 2015
- Posted
- December 9, 2015
- Recall Number
- D-0393-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
- Firm Location
- Mount Vernon, NY, United States
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Distribution
Nationwide
Lot / Code Info
Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036
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