FDA (Drugs) recall action 90982

Pharmacy Plus, Inc. dba Vital Care Compounder recalled 32 products on 2022-11-09

The FDA (Drugs) publishes a recall like this one as 32 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 32 pages.

Products: 32
Announced: 2022-11-09
Critical: 0
Units: 2,876

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 32

HighFDA (Drugs)··2022-11-09
Ceftazidime Intravitreal Solution Recalled for Sterility Assurance Failure
Vital Care Compounder is recalling Ceftazidime intravitreal injection solutions due to manufacturing conditions that cannot guarantee product sterility. Affected lots were distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee.
Product
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Compounded Injectable Drug Recalled Due to Sterility Assurance Defect
A compounded injectable medication containing papaverine, phentolamine, and prostaglandin was recalled after FDA inspection found it was not produced under conditions that guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
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
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Pharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a compounded injectable medication (56 vials) due to manufacturing processes that cannot guarantee product sterility. Distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Prescription eye drops recalled due to sterility assurance defect
Vital Care Compounder is recalling 378 droptainers of PRED ACETATE/GATIFLOXACIN eye drops distributed in AL, LA, MS, and TN due to inability to guarantee manufacturing sterility. No illnesses have been reported.
Product
PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Lidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect
Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance
A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in AL, LA, MS, and TN.
Product
LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Voriconazole ophthalmic solution recalled for sterility concerns
Pharmacy Plus, Inc. (Vital Care Compounder) is recalling Voriconazole Ophthalmic Solution 2% because FDA inspection found manufacturing processes cannot guarantee the product's sterility.
Product
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Moxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
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
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Mitomycin Injection Recalled Due to Lack of Sterility Assurance
Vital Care Compounder is recalling 185 syringes of Mitomycin Injection due to lack of sterility assurance discovered during FDA inspection. The product cannot guarantee sterility.
Product
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
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Phentolamine Injectable Drug Recalled Due to Sterility Concerns
Pharmacy Plus recalls Phentolamine 10MG/ML injection due to lack of guaranteed sterility during production. Affected lots distributed to AL, LA, MS, and TN.
Product
PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Prostaglandin E1 Injection Recalled Due to Sterility Assurance Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution after FDA inspection found the products were manufactured in a manner that cannot guarantee sterility.
Product
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Acetylcysteine Eye Drops Recalled for Sterility Assurance Issues
Acetylcysteine ophthalmic solution 5% from Vital Care Compounder is recalled due to manufacturing deficiencies that cannot ensure product sterility. The affected product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Pharmacy Compounded Injection Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable medication because manufacturing did not ensure sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Acetylcysteine eye drops recalled for sterility assurance defect
Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.
Product
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
FDA Recalls Cefuroxime Intravitreal Injections for Sterility Defect
Pharmacy Plus Inc. recalls 460 syringes of compounded Cefuroxime intravitreal solution distributed in Alabama, Louisiana, Mississippi, and Tennessee due to manufacturing sterility defect.
Product
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Sterile Talc Powder Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling sterile talc powder vials after FDA inspection found the manufacturing process cannot guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Prescription Injectable Medication Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a prescription injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found the product was produced in a manner that cannot guarantee sterility. Lot 65976 (BUD 10/27/2022) was distributed in AL, LA, MS, and TN.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure
Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Vital Care Compounder is recalling an injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found production methods cannot guarantee product sterility. The recalled lot was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Lidocaine-Epinephrine Injectable Solution Recalled for Sterility Assurance Issues
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.
Product
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Injectable hormone medication recalled for sterility assurance failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.
Product
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues
Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states
HighFDA (Drugs)··2022-11-09
Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
Product
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Distribution
4 states