January 22, 2020DrugsFDA
Assurance Infusion recalls BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharm
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 coun
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
January 22, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 v
Hazard: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
January 22, 2020DrugsFDA
Motto International Corp recalls Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
January 22, 2020DrugsFDA
Motto International Corp recalls Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packagi
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
January 22, 2020DrugsFDA
Motto International Corp recalls Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packag
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil