Agency classClass IIOur severity:High FDA (Drugs)·D-0239-2023·Announced 2023-02-01

Injectable vitamin B-complex products recalled for lack of sterility assurance

Pharmacy Innovations is recalling three injectable vitamin B-complex products nationwide due to insanitary conditions discovered during FDA inspection. The products lack assurance of sterility and may pose contamination risk.

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 is an FDA Class II recall involving lack of sterility assurance in injectable drugs—a high-risk product category. No illnesses or injuries have been reported. The hazard is based on insanitary conditions discovered during inspection that create potential for contamination, placing this in the High category per the rubric criterion: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pharmacy Innovations is recalling three injectable vitamin B-complex formulations manufactured at its facility in Erie, PA. The recalled products contain B vitamins including thiamine, riboflavin, niacinamide, dexpanthenol, pyridoxine, and in some formulations hydroxycobalamin, methylfolate, or methylcobalamin. All are Rx only.

The recall was initiated due to lack of assurance of sterility. During an FDA inspection, insanitary conditions were discovered at the manufacturing facility that could compromise the sterility of injectable products.

The affected products were distributed nationwide. The specific lot codes subject to recall are t20221116@36, t20221121@42, and t20221021@32.

The recalled product

Product: THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE…
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable vitamin B-complex
Hazard: lack-of-sterility
contamination

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)

t20221116@36 t20221121@42 t20221021@32

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 · lack of sterility