Recalls / Class II
Class IID-0577-2020
Product
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
- Brand name
- Dextrose
- Generic name
- Dextrose Monohydrate
- Active ingredient
- Dextrose Monohydrate
- Route
- Intravenous
- NDC
- 0409-1775
- FDA application
- NDA019445
- Affected lot / code info
- Lot #: 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or expiration date.
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
- 77,100 syringes
- Distribution pattern
- Nationwide within the United States including Puerto Rico.
Timeline
- Recall initiated
- 2019-11-27
- FDA classified
- 2019-12-06
- Posted by FDA
- 2019-12-18
- Terminated
- 2022-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0577-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.