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Recall 2019: Mylan - Levoleucovorin Injection - Consumer


URGENT!!!            DRUG RECALL!!!            URGENT!!!

Description Lot # Exp Date         NDC
LEVOLEUCO SDV 250MG/25ML APB032 4/30/2019    67457060130
  APB033 4/30/2019    

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots of Levoleucovorin Injection, 250 mg/25 mL to the consumer level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing. Affected product started shipping August 01, 2017.

Consumer: Please contact Stericycle at 1-866-551-2706 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. - 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Contact:

Stericycle: Stericycle Customer Service 866-551-2706