Recalls / Class III
Class IIID-1184-2018
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
- Affected lot / code info
- Lot: DP602, 10/2018
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 1,580 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-08-28
- FDA classified
- 2018-09-07
- Posted by FDA
- 2018-09-19
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1184-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.