Lack of Assurance of Sterility
Drugs Recalls
Prescription and over-the-counter medications
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
KRS Global Biotechnology
Lack of Assurance of Sterility
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
KRS Global Biotechnology
Lack of Assurance of Sterility
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
KRS Global Biotechnology
Lack of Assurance of Sterility
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
KRS Global Biotechnology
Lack of Assurance of Sterility
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
KRS Global Biotechnology
Lack of Assurance of Sterility
OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
KRS Global Biotechnology
Lack of Assurance of Sterility
C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000
KRS Global Biotechnology
Lack of Assurance of Sterility
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
KRS Global Biotechnology
Lack of Assurance of Sterility
fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300
KRS Global Biotechnology
Lack of Assurance of Sterility
Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103
KRS Global Biotechnology
Lack of Assurance of Sterility
Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967
KRS Global Biotechnology
Lack of Assurance of Sterility
C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500
KRS Global Biotechnology
Lack of Assurance of Sterility
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
KRS Global Biotechnology
Lack of Assurance of Sterility
C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Lack of Assurance of Sterility