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  3. Recall Enforcement Event ID: 77960

Recall Enforment Report D-0224-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmatech LLC, originally initiated on 08-16-2017 for the product Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL The product was recalled due to microbial contamination of non sterile product; presence of yeast and potential b. cepacia contamination. The product was distributed in Mi and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0224-201808-16-201701-24-2018Class IIUnknownRugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FLMicrobial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contaminationTerminated
D-0227-201808-16-201701-24-2018Class IIUnknownRugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FLMicrobial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contaminationTerminated
D-0225-201808-16-201701-24-2018Class IIUnknownRugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FLMicrobial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contaminationTerminated
D-0226-201808-16-201701-24-2018Class IIUnknownRugby 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, FLMicrobial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contaminationTerminated