Recalls / Class II
Class IID-1790-2019
Product
METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE 98 MG / 3.92 ML IM SYR; METHOTREXATE 55 MG / 2.2 ML IVP; METHOTREXATE 59.5 MG / 2.38 ML IVP; METHOTREXATE 12 mg QS 6 ml 0.9% NACL; METHOTREXATE 150 MG / 50 ML NS IVPB; METHOTREXATE 112.5 MG/ 4.5 ML IM SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Infusion Options, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5924 13th Ave, N/A, Brooklyn, New York 11219-4934
Distribution
- Quantity
- N/A
- Distribution pattern
- NY only
Timeline
- Recall initiated
- 2019-06-12
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1790-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.