Agency classClass IIOur severity:High FDA (Drugs)·D-0041-2023·Announced 2022-11-09

Compounded injectable medication recalled for lack of sterility assurance

Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a sterile injectable product where manufacturing controls failed to ensure sterility. While no illnesses or injuries have been reported, the lack of sterility assurance in a sterile injectable represents a significant risk-of-harm product, meeting criteria for High severity.

Plain-English summary

Pharmacy Plus, Inc., operating as Vital Care Compounder in Hattiesburg, Mississippi, is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections in 5 mL vials. The recall affects two specific lot numbers: Lot 66369 with a beyond-use date of November 6, 2022, and Lot 66540 with a beyond-use date of November 9, 2022.

The FDA inspection revealed that these products were manufactured in a manner that cannot guarantee their sterility. Sterile injectable medications are critical drugs where sterility is essential to patient safety, as non-sterile products pose a serious risk of infection.

The recalled products were distributed to healthcare facilities in Alabama, Louisiana, Mississippi, and Tennessee. Healthcare providers who received these products should immediately identify and quarantine them and contact Pharmacy Plus for return instructions. Patients who may have received doses from the recalled lots should contact their healthcare provider.

No illnesses or injuries have been reported in connection with this recall. Anyone with questions should contact Pharmacy Plus, Inc. with the FDA recall number D-0041-2023.

The recalled product

Product: 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
Manufacturer: Pharmacy Plus, Inc. dba Vital Care Compounder
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lots: 66369
BUD: 11/06/2022
66540
BUD: 11/09/2022

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder

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Same hazard · lack of sterility