FDA, Sandoz recall methotrexate

May 21, 2013

The U.S. Food and Drug Administration (FDA) announced this morning that Sandoz is conducting a voluntary recall of its Methotrexate Sodium USP, 25 mg/mL, 40 mL injectable products. The manufacturer discovered particulate matter in vials during a routine quality inspection of retention samples.

 

The Food and Drug Administration announced that Sandoz is conducting a voluntary recall of its Methotrexate Sodium USP, 25 mg/mL, 40 mL injectable products. The manufacturer discovered particulate matter in vials during a routine quality inspection of retention samples.

The two lots being recalled are CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the U.S. and to Poland, according to the FDA safety alert.

Although Sandoz is not aware of any related adverse events, use of injections from the affected lots can lead to microembolisation in areas where the particles lodge, the FDA warns.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

Healthcare professionals are asked to report any adverse reactions or quality problems involving this product directly to the Sandoz Drug Information Direct Line at 800-525-2492. Reports can also be made via email at qa.druginfo@sandoz.com.

Adverse events or side effects related to the use of these products should also be reported to the FDA's MedWatch Safety.