Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Reports. Newly announced recalls may appear on FDA.gov before they become available in
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Showing 7,801–7,820 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass II
Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.
by Torrent Pharma Inc
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
May 21, 2019
Reported by FDA
June 19, 2019
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
