Methotrexate Injectable Vials Recalled for Lack of Sterility Assurance
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for an injectable product with lack of sterility assurance due to facility sanitation issues. No illnesses or injuries have been reported, making this a risk-of-harm product without documented injury, warranting a score of 3 (High).
Plain-English summary
Pharmacy Innovations is recalling Methotrexate intravitreal injectable solution (1mL vial, 4mg/mL concentration) distributed nationwide in the United States. The affected batch code is t20221011@36.
The recall was initiated due to lack of assurance of sterility at the manufacturing facility. An FDA inspection revealed insanitary conditions that compromise the sterile status required for safe injectable medications.
Healthcare providers and patients who received this product should contact their pharmacist or healthcare provider. It is important not to stop prescribed methotrexate therapy without consulting with a healthcare provider.
Patients concerned about whether they received an affected batch can provide the batch code t20221011@36 to their healthcare provider or pharmacist for verification.
The recalled product
- Product
- METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- t20221011@36
Distribution
Distributed nationwide across the United States.
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