Geritrex recalls
Geritrex appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2019-07-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 15 |
|---|---|
| Published | 2015-07-22 to 2019-07-31 |
| By agency | FDA Drug (15) |
| By classification | Class II (14), Class III (1) |
| By status | terminated (15) |
| Distribution named in notices | US |
Recalls
- Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd…
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, N…
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Stre…
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-…
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Cor…
FDA Drug · Class II · 2019-07-31 · Geritrex
Reason: cGMP Deviations: Products may have microbial contamination. - Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC…
FDA Drug · Class II · 2019-06-19 · Geritrex
Reason: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported - Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 5416…
FDA Drug · Class II · 2019-06-19 · Geritrex
Reason: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported - Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use o…
FDA Drug · Class II · 2015-12-09 · Geritrex
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. - GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 105…
FDA Drug · Class II · 2015-12-09 · Geritrex
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. - Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Ver…
FDA Drug · Class II · 2015-12-09 · Geritrex
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. - 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), Distribu…
FDA Drug · Class II · 2015-12-09 · Geritrex
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. - Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporati…
FDA Drug · Class III · 2015-07-22 · Geritrex
Reason: CGMP Deviation: Poor container closure of the bulk storage container