Agency classClass IIOur severity:High FDA (Drugs)·D-0242-2023·Announced 2023-02-01

Injectable Vitamin D3 Products Recalled for Lack of Sterility Assurance

Pharmacy Innovations is recalling injectable Vitamin D3 products nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.

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 injectable medications where sterility cannot be assured due to facility sanitation failures. While no illnesses have been reported, injectable products with compromised sterility assurance represent a risk-of-harm scenario, meeting the rubric criterion for High severity.

Plain-English summary

Pharmacy Innovations is recalling injectable Vitamin D3 products distributed nationwide: Vitamin D3-Aqueous 10,000 IU/mL and Vitamin D3-PF-Ethyl Oleate 50,000 IU/mL (1 mL vials). Both are prescription medications.

The recall was initiated following an FDA inspection that discovered insanitary conditions at the Pharmacy Innovations facility in Erie, Pennsylvania. These conditions raise concerns about the ability to assure sterility for injectable products manufactured under those conditions.

Patients who have received these products should contact their healthcare provider. Healthcare providers should identify affected patients and remove recalled products from inventory. The products are identified by specific lot codes: t20221017@25 and t20221013@15. No illnesses or adverse events have been reported in connection with these products.

The recalled product

Product: VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable
Hazard: sterility-assurance
contamination-risk

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)

t20221017@25 t20221013@15

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