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 Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Found during examination of retention samples.
What was recalled
Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
- Recalling firm
- Sandoz Incorporated
- NDC code
- 66758-041-01
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-832-2013
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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