Multi-event October 2022 FDA Recall Drug by Pharmacy Plus, Inc. Dba Vital Care Compounder

This Multi-event Class II drug recall was voluntarily initiated by Pharmacy Plus, Inc. Dba Vital Care Compounder on October 7, 2022 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in AL, LA, MS, and TN and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-0033-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 droptainer

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65416, BUD: 10/13/2022

Recall Number: D-0049-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65976, BUD: 10/27/2022

Recall Number: D-0044-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65425, BUD: 10/13/2022

Recall Number: D-0027-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
2 droptainers

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 66017, BUD: 10/13/2022; 66177, BUD: 10/19/2022

Recall Number: D-0040-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
106 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66470, BUD: 11/10/2022

Recall Number: D-0031-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
460 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 63265, BUD: 01/24/2023; 66085, BUD: 04/03/2023

Recall Number: D-0057-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 droptainer

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66757, BUD: 10/14/2022

Recall Number: D-0053-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
800.5 mL in unit dose vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
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

Batch or Lot Expiration Information

Lot# Lots: 65680, BUD: 10/11/2022; 66043, BUD: 10/15/2022; 66372, BUD: 10/23/2022; 66597, BUD: 10/29/2022

Recall Number: D-0036-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
7 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66591, BUD: 11/12/2022

Recall Number: D-0028-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
168 droptainers

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 65605, BUD: 10/16/2022; 65658, BUD: 10/17/2022; 65733, BUD: 10/21/2022; 65894, BUD: 10/24/2022; 66019, BUD: 10/28/2022; 66120, BUD: 10/30/2022; 66388, BUD: 11/6/2022; 66755, BUD: 11/14/2022; 66870, UD: 11/18/2022; 66928, BUD: 11/19/2022

Recall Number: D-0045-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 66450, BUD: 11/07/2022; 66527, BUD: 11/09/2022

Recall Number: D-0046-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
242 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 55092, BUD: 10/22/2022; 59100, BUD: 10/30/2022; 62038, BUD: 04/08/2023; 66533, BUD: 04/08/2023

Recall Number: D-0038-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
514 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
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

Batch or Lot Expiration Information

Lot# Lot: 57997, BUD: 02/25/2023; 64941, BUD: 03/08/2023

Recall Number: D-0048-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
5 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65594, BUD: 10/16/2022

Recall Number: D-0052-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
50 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 59993 BUD: 10/18/2022; 60932 BUD: 11/09/2022

Recall Number: D-0026-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 droptainer

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66895, BUD: 11/19/2022

Recall Number: D-0043-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66576, BUD: 11/09/2022

Recall Number: D-0041-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 66369, BUD: 11/06/2022; 66540, BUD: 11/09/2022

Recall Number: D-0042-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
56 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 64409, BUD: 04/08/2023; 60849, BUD: 05/23/2023

Recall Number: D-0035-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
389 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65972, BUD: 10/27/2022

Recall Number: D-0047-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
28 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 60552, BUD: 03/12/2023

Recall Number: D-0037-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
40 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 55786, BUD: 12/31/2022

Recall Number: D-0050-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
10 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 60586, BUD: 11/01/2022; 64203, BUD: 01/28/2023

Recall Number: D-0051-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
378 droptainers

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 65056, BUD: 11/18/2022; 66246, BUD: 11/19/2022

Recall Number: D-0055-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 65995, BUD: 10/28/2022

Recall Number: D-0034-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 66513, BUD: 11/10/2022

Recall Number: D-0054-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
45 droptainers

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 65490, BUD: 10/14/2022; 65584, BUD: 10/16/2022; 66013, BUD: 10/28/2022

Recall Number: D-0029-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
86 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lot: 60448 BUD: 10/31/2022

Recall Number: D-0039-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
185 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 60618, BUD: 5/6/2023; 66536, BUD: 7/8/2023

Recall Number: D-0030-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
12 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 65434, BUD: 10/13/2022; 66349, BUD: 11/05/2022; 66868, BUD: 11/18/2022

Recall Number: D-0056-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
12 syringes

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 65432, BUD: 10/13/2022; 66347, BUD: 11/05/2022; 66864, BUD: 11/18/2022

Recall Number: D-0032-2023

Reason for Recall
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.
Initiated
10-07-2022
Reported
11-09-2022
Quantity
67 bottles

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pharmacy Plus, Inc. dba Vital Care Compounder
AL, LA, MS, and TN
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Batch or Lot Expiration Information

Lot# Lots: 59638, BUD: 11/25/2022; 64261, BUD: 04/30/2023