Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
Hospira is recalling specific lots of Fentanyl Citrate Injection ampules because broken tips may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Hospira Inc. is recalling 797,800 ampules of Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL. The affected product is identified by NDC 0409-4093-32 and includes Lot #5 9277EV, 60028EV, and 6008EV, with an expiration date of 11/1/17. The recall is due to complaints of broken tips on the ampules, which creates a lack of assurance of sterility.
The affected product was distributed nationwide. This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not used until further notice.
The recalled product
- Product
- Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 797,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #5 9277EV
- 60028EV
- 6008EV
- Exp 11/1/17
Distribution
Distributed nationwide across the United States.
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