TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack of sterility assurance.
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ
Sun Pharmaceutical Industries
Class I - Dangerous
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
Class I - Dangerous
Lack of sterility assurance.
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API