CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0031-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0032-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0035-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0049-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0038-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0036-2023November 9, 2022Hattiesburg, MS
Pharmacy Plus, Inc. dba Vital Care Compounder
Class IIOngoing
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
D-0053-2023November 9, 2022Hattiesburg, MS
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 0...
Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
D-0015-2023October 26, 2022Waltham, MA
CIPLA
Class IITerminated
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials ...
Reason: Lack of Assurance of Sterility: environmental monitoring failure.
D-1550-2022October 12, 2022Warren, NJ
CIPLA
Class IITerminated
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured fo...
Reason: Lack of Assurance of Sterility
D-1545-2022October 5, 2022Warren, NJ
Carolina Infusion
Class IICompleted
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1531-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1529-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1523-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1530-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1533-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1516-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1534-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1527-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1521-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1520-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1518-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1519-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1526-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1524-2022September 21, 2022Ridgeland, SC
Pine Pharmaceuticals, LLC
Class IITerminated
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, ...