PlainRecalls
FDA Drug Verify with FDA Drug → Moderate Class II Ongoing

PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Reported: November 9, 2022 Initiated: October 7, 2022 #D-0042-2023 56 vials units

Pharmacy Plus, Inc. dba Vital Care Compounder issued this FDA Drug recall on November 9, 2022. Classified as Moderate severity (Class II). Approximately 56 vials units are affected. The recall was issued because: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guaran…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Drug action (record #D-0042-2023) was formally reported on November 9, 2022, with the manufacturer initiating the action on October 7, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Pharmacy Plus, Inc. dba Vital Care Compounder is listed as the recalling firm, operating out of Hattiesburg, MS. Federal records indicate 56 vials units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: AL, LA, MS, and TN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

56 vials

Related Recalls

6

0 from same agency

Product Description

PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

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.

Details

Units Affected
56 vials
Distribution
AL, LA, MS, and TN
Location
Hattiesburg, MS

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number D-0042-2023
Date reported November 9, 2022
Date initiated October 7, 2022
Recalling firm Pharmacy Plus, Inc. dba Vital Care Compounder
Units affected 56 vials
Distribution AL, LA, MS, and TN

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

56 vials units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402. Recalled by Pharmacy Plus, Inc. dba Vital Care Compounder. Units affected: 56 vials.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 9, 2022. Severity: Moderate. Recall number: D-0042-2023.
Where was the recalled product distributed?
Distribution: AL, LA, MS, and TN.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0042-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).