Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified…
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Reason CGMP Deviations
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
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