Home / Recalls / Geritrex, LLC / D-1520-2019

D-1520-2019 Class II Terminated

Recalled by Geritrex, LLC — Middletown, NY

Recall Details

Product Type
Drugs
Report Date
July 31, 2019
Initiation Date
May 31, 2019
Termination Date
February 2, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8645 bottles

Product Description

Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04

Reason for Recall

cGMP Deviations: Products may have microbial contamination.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: 70606, Exp 6/19

Other recalls by Geritrex, LLC

  • D-1525-2019 Class II — Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation (May 31, 2019)
  • D-1521-2019 Class II — Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporatio (May 31, 2019)
  • D-1522-2019 Class II — Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 (May 31, 2019)
  • 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-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)
  • D-0390-2016 Class II — Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) (October 27, 2015)