Recalls / Class II
Class IID-0136-2020
Product
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
- Brand name
- Lmd In Dextrose
- Generic name
- Dextran 40
- Active ingredient
- Dextran 40
- Route
- Intravenous
- NDCs
- 0409-7418, 0409-7419
- FDA application
- BA720563
- Affected lot / code info
- Lot #: 87-095-JT Exp. 1MAR2020
Why it was recalled
Lack of Assurance of Sterility: Bag has the potential to leak.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 17832 bags
- Distribution pattern
- Nationwide in the United States and Puerto Rico
Timeline
- Recall initiated
- 2019-10-02
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2020-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0136-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.