Agency classClass IIOur severity:High FDA (Drugs)·D-0198-2023·Announced 2023-02-01

Injectable Vitamin D3 Recalled Over Sterility Concerns at Manufacturing Facility

Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility assurance.

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: FDA Class II recall with no reported illnesses or injuries. The hazard—insanitary facility conditions affecting a sterile injectable product—represents a contamination risk without confirmed harm, placing this at High severity.

Plain-English summary

Pharmacy Innovations, located in Erie, Pennsylvania, has recalled Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide. The recall was initiated after FDA inspection revealed insanitary conditions at the manufacturing facility.

The product is an injectable vitamin D3 supplement available only by prescription. Because it is an injectable preparation, any compromise to sterility assurance poses a potential health risk. The insanitary conditions found during FDA inspection raise concerns that the manufacturing environment may not meet required standards for producing sterile injectable pharmaceuticals.

Patients currently using this product should consult their healthcare provider immediately. Do not stop taking your medication without medical guidance. Your healthcare provider can advise whether this product should be discontinued or replaced with an alternative source of vitamin D supplementation.

Healthcare providers and pharmacies should quarantine all affected inventory and return it to the manufacturer according to the recall instructions.

The recalled product

Product: Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable / Vitamin Supplement
Hazard: sterility-assurance
insanitary-conditions

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 (1)

t20221130@14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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Same hazard · sterility assurance