Hospira Recalls Vancomycin Hydrochloride Injection Due to Particulate Matter
Hospira is recalling 30,880 vials of Vancomycin Hydrochloride for Injection because a hair was found inside a vial and contacted the drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this as an FDA Class I recall, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Hospira Inc., a Pfizer company, is recalling 30,880 vials of Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package. The product is packaged in 100 mL glass vials and is intended for intravenous use. The specific lot affected is # 591053A, with an expiration date of 11/1/2017.
The recall was initiated due to the presence of particulate matter. Specifically, a hair was found stuck to the stopper inside a single vial. This hair came into contact with the reconstituted drug product. The agency has classified this recall as Class I.
The affected product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected lot and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Drug — Antibiotic Injection
- Affected units
- 30,880
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 (2)
- Lot # 591053A
- Exp 11/1/2017
Distribution
Distributed nationwide across the United States.
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