Recalls / Class III
Class IIID-0980-2017
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
- Affected lot / code info
- Lot: DP601, exp 10/2018
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Recalling firm
- Firm
- Hospira Inc., A Pfizer Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 701 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-06
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2019-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0980-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.