Sandoz Recalls Methotrexate Injection Vials Due to Particulate Matter
Sandoz Incorporated is recalling specific lots of Methotrexate Injection vials because particulate matter was found in retention samples.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Sandoz Incorporated is recalling 1,635 vials of Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial. The recall involves products with NDC 66758-041-01, manufactured for Sandoz Inc. in Princeton, NJ, and manufactured by EBEWE Pharma Ges.m.b.H. Nfg.KG in Austria.
The recall was initiated because particulate matter was found during the examination of retention samples. The affected lots are CL0996 (Expiration 12/13) and CJ4948 (Expiration 05/13). The products were distributed nationwide.
Healthcare providers and patients should stop using the affected vials and contact Sandoz Incorporated for further instructions or to arrange for a return.
The recalled product
- Product
- 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.
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,635
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 (4)
- Lot #: CL0996
- Exp 12/13
- and CJ4948
- Exp 05/13
Distribution
Distributed nationwide across the United States.
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