Recalls / Class I
Class ID-1328-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.
- Affected lot / code info
- Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, N/A, Rockford, Illinois 61103-1287
Distribution
- Quantity
- a) 15,095 vials b) 300 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-03-18
- FDA classified
- 2015-08-13
- Posted by FDA
- 2015-08-19
- Terminated
- 2016-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1328-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.