Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

FDA recall notice · announced September 19, 2018 · 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), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Reason for recall

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

Notes

Distribution: Nationwide USA
Lot/code information: Lot: DP602, 10/2018
Quantity: 1,580 vials
Status: Terminated
Products in this recall event:
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01 (D-1184-2018)

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