Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Product description
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
Lot numbers, UPCs & expiration codes
Lot: DP601, exp 10/2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0980-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- 701 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc., A Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0980-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77687
- Address
- 275 N Field Dr
- Code information
- Lot: DP601, exp 10/2018
- Postal code
- 60045-2579
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0980-2017
- Classification
- Class III
- Recalling firm
- Hospira Inc., A Pfizer Company
- Product quantity
- 701 vials
- Termination date
- Sep 10, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2017