Class III · Low risk Completed
Methotrexate Tablets
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Methotrexate 25mg/mL Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
What was recalled
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
- Recalling firm
- The Compounding Shop, INC.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-548-2013
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.
Other Methotrexate recalls
See all
Class III · Low risk Ongoing
Methotrexate Tablets
Reason Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class II · Moderate risk Terminated
Methotrexate Intravitreal
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Methotrexate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methotrexate Injection
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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