January 30, 2019DrugsFDA
Bound Tree Medical, LLC recalls curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1
Hazard: Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
January 23, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b)
Hazard: Failed dissolution specifications
January 23, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: CGMP Deviation; manufacturing batch record could not be located
January 23, 2019DrugsFDA
Bound Tree Medical, LLC recalls Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep P
Hazard: Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
January 23, 2019DrugsFDA
Syntho Pharmaceuticals, Inc. recalls EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: S
Hazard: CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
January 23, 2019DrugsFDA
Syntho Pharmaceuticals, Inc. recalls EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured
Hazard: CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
January 23, 2019DrugsFDA
Bound Tree Medical, LLC recalls curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101)
Hazard: Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810.
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 16, 2019DrugsFDA
Allergan, PLC. recalls OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,
Hazard: GMP Deviations: A silicone particulate was noted in Ozurdex.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only
Hazard: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only
Hazard: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
January 16, 2019DrugsFDA
PharMEDium Services, LLC. recalls 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% B
Hazard: Subpotent
January 16, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manu
Hazard: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
January 16, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Man
Hazard: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured fo
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjaw
Hazard: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
January 16, 2019DrugsFDA
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only
Hazard: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
January 16, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-71
Hazard: Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator