Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

FDA recall notice · announced July 26, 2017 · Hospira Inc., A Pfizer

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

Reason for recall

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

Notes

Distribution: Nationwide
Lot/code information: Lot: DP601, exp 10/2018
Quantity: 701 vials
Status: Terminated
Products in this recall event:
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 (D-0980-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.