Class I - Dangerous
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.
💊
Prescription Drugs
💊 Drugs • 11,927 recalls
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
ACP Nimble Buyer
Class I - Dangerous
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class I - Dangerous
Lack of assurance of sterility.
Class I - Dangerous
CGMP Deviations
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Valeant Pharmaceuticals North America
Class I - Dangerous
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.