Home / Recalls / Pharmatech LLC / D-0226-2018

D-0226-2018 Class II Terminated

Recalled by Pharmatech LLC — Davie, FL

Recall Details

Product Type: Drugs
Report Date: January 24, 2018
Initiation Date: August 16, 2017
Termination Date: January 4, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Unknown

Product Description

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL

Reason for Recall

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

Distribution Pattern

Code Information

All lots remaining within expiry.

Other recalls by Pharmatech LLC

F-0633-2018 Class II — Major Poly-Vita Drops w/ Iron 50 mL UPC 00904-5100-50 (August 16, 2017)
F-0624-2018 Class II — Rugby Calcionate Syrup 16 oz. UPC 00536-2770-85 (August 16, 2017)
D-0227-2018 Class II — Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL (August 16, 2017)
F-0627-2018 Class II — Leader Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL UPC 096295 (August 16, 2017)
D-0225-2018 Class II — Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pi (August 16, 2017)
D-0224-2018 Class II — Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One P (August 16, 2017)
F-0630-2018 Class II — Major Poly-Vita Drops 50 mL UPC 00904-5099-50 (August 16, 2017)
F-0634-2018 Class II — Rugby Poly-Vitamin w/ Iron Liquid 50 mL UPC 00536-8530-80 (August 16, 2017)
F-0620-2018 Class II — Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97 (August 16, 2017)
F-0636-2018 Class II — Major Certa-Vite Liquid 236 mL UPC 00904-5023-09 (August 16, 2017)