Defective container:may contain bottles with incomplete seals
Drugs Recalls
Prescription and over-the-counter medications
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
Defective container:may contain bottles with incomplete seals
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
IntegraDose Compounding Services
Subpotent Drug
Failed Dissolution Specifications
Defective container:may contain bottles with incomplete seals
CGMP Deviations; deficiencies observed during FDA inspection
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Ajanta Pharma USA
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Keystone Industries
Defective container:may contain bottles with incomplete seals
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Keystone Industries
Defective container:may contain bottles with incomplete seals
CGMP Deviations; deficiencies observed during FDA inspection