Recalls / Class I
Class ID-0862-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, 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 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
Why it was recalled
Presence of Particulate Matter: human hair found within an internal sample syringe.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 71,550 syringes
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-04-21
- FDA classified
- 2017-05-24
- Posted by FDA
- 2017-05-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0862-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.