June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hin
Hazard: Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
June 19, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hi
Hazard: Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
June 19, 2019DrugsFDA
Bausch & Lomb recalls Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pha
Hazard: Failed Stability Specifications: Out of specification for viscosity.
June 19, 2019DrugsFDA
Novis PR, Inc. recalls Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free,
Hazard: Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
June 19, 2019DrugsFDA
Fresenius Kabi USA, LLC recalls Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 6332
Hazard: Failed Impurities/Degradation Specifications.
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Bisacodyl Suppositories, Brite Stock, Reese.
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL)
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) b
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc.,
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) ND
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd fo
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC:
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories p
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, N
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Phar
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Man
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., N
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97,
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) O
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottl
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle,
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Fre
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 19, 2019DrugsFDA
Torrent Pharma Inc recalls Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. o
Hazard: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).