Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Product description
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
Lot numbers, UPCs & expiration codes
Lot: DP602, 10/2018
Where it was sold
Nationwide USA
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-1184-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 28, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 1,580 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1184-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 80923
- Address
- 235 E 42nd St
- Code information
- Lot: DP602, 10/2018
- Postal code
- 10017-5703
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1184-2018
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1,580 vials
- Termination date
- Jun 26, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 28, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2018