Drug and pharmaceutical recalls

17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-01-22FDA-DrugAssurance InfusionClass II
BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
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
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAssurance InfusionClass II
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
Lack of sterility assurance.
2020-01-22FDA-DrugAVKARE Inc.Class II
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
2020-01-22FDA-DrugSun Pharmaceutical Industries, Inc.Class II
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
2020-01-22FDA-DrugSun Pharmaceutical Industries, Inc.Class II
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
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
2020-01-22FDA-DrugHikma Pharmaceuticals USA Inc.Class II
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
2020-01-22FDA-DrugMotto International CorpClass I
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
2020-01-22FDA-DrugMotto International CorpClass I
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
2020-01-22FDA-DrugMotto International CorpClass I
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
2020-01-22FDA-DrugMotto International CorpClass I
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
2020-01-15FDA-DrugIdelle LabsClass III
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugIdelle LabsClass III
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugIdelle LabsClass III
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugIdelle LabsClass III
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAppco Pharma LLCClass II
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-15FDA-DrugAppco Pharma LLCClass II
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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