Agency classClass IIOur severity:High FDA (Drugs)·D-0202-2023·Announced 2023-02-01

Injectable Drug Recall: Lack of Sterility Assurance at Manufacturing Facility

Pharmacy Innovations is recalling an injectable medication due to lack of sterility assurance caused by insanitary conditions at the manufacturing facility. Affected vials were distributed nationwide.

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 drug recall with lack of sterility assurance due to insanitary manufacturing conditions. No illnesses or injuries reported, but injectable medications require strict sterile conditions; the facility's insanitary conditions create a high-risk situation without yet-manifested harm.

Plain-English summary

Pharmacy Innovations is recalling Dexpanthenol/Pyridoxine/Hydroxocobalamin 250MG/100MG/1MG/ML injectable medication in 1ML vials distributed nationwide. The recall was initiated due to an FDA inspection that revealed insanitary conditions at the manufacturing facility.

Insanitary facility conditions compromise the assurance that injectable medications have been properly sterilized. Injectable medications must be manufactured under strict sterile conditions, and the insanitary conditions identified by FDA inspection create a risk that these vials may not meet required sterility standards.

Patients and healthcare providers should not use affected vials. Those with questions should contact their healthcare provider or pharmacist. The affected lots are identified by the codes t20221012@64 and t20221114@18.

The recalled product

Product: Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable Medication
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 (2)

t20221012@64
t20221114@18

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