The Recall Desk
HighFDA (Drugs)·D-0236-2023·Announced 2023-02-01

Semaglutide Injectable Vials Recalled for Lack of Sterility Assurance

Pharmacy Innovations is recalling Semaglutide injectable vials in multiple strengths distributed nationwide due to insanitary facility conditions compromising sterility. No illnesses have been reported.

What this means for you

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 for lack of sterility assurance in injectable pharmaceuticals due to insanitary facility conditions. Although no illnesses or injuries have been reported, injectable products with compromised sterility represent a significant risk of harm, warranting a High severity rating per the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pharmacy Innovations is recalling multiple strengths of Semaglutide injectable vials distributed nationwide in the United States. The affected products include vials containing 0.5 mg/mL, 1 mg/mL, 2 mg/mL, 4 mg/mL, and 5.4 mg/mL Semaglutide in 0.5 mL vials.

The recall was initiated due to lack of assurance of sterility. An FDA inspection of the Pharmacy Innovations facility in Erie, Pennsylvania revealed insanitary conditions that may have compromised the sterility of these products.

Affected lot codes include t20221026@52, t20221102@11, t20221004@44, t20221116@36, and t20221011@36. No illnesses or injuries have been reported in connection with these products to date.

Consumers who have received these products should contact their healthcare provider or pharmacy for guidance on replacement or alternative treatments.

The recalled product

Product
SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer
Pharmacy Innovations
Category
Drug — Semaglutide / Injectable
Hazard
  • lack-of-sterility
  • 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)

  • t20221026@52 t20221102@11 t20221004@44 t20221116@36 t20221011@36

Distribution

Distributed nationwide across the United States.

Related recalls

Same category