May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charl
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlott
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Johnson Matthey Inc. recalls Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass con
Hazard: Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
April 24, 2019DrugsFDA
Brian P. Richardson recalls Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Ma
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
April 24, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle
Hazard: Subpotent Product: assay results for Amoxicillin were below the specification limits.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, T
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compou
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, B
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy,
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 B
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN
Hazard: Lack of sterility assurance.