Home / Recalls / Geritrex Corp / D-0393-2016

D-0393-2016 Class II Terminated

Recalled by Geritrex Corp — Mount Vernon, NY

Recall Details

Product Type
Drugs
Report Date
December 9, 2015
Initiation Date
October 27, 2015
Termination Date
June 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350

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.

Distribution Pattern

Nationwide

Code Information

Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036

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  • D-1527-2019 Class II — Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. (May 31, 2019)
  • D-1524-2019 Class II — Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), (May 31, 2019)
  • D-1526-2019 Class II — Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 (May 31, 2019)
  • D-1523-2019 Class II — Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Dis (May 31, 2019)
  • D-1521-2019 Class II — Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporatio (May 31, 2019)
  • D-1437-2019 Class II — Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritr (May 6, 2019)
  • D-1436-2019 Class II — Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals (May 6, 2019)