Hospira Recalls Vancomycin Hydrochloride Vials Due to Mislabeling
Hospira Inc. is recalling 316,640 vials of Vancomycin Hydrochloride for Injection because product trays were mislabeled to contain a different product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a packaging/labeling error rather than a contamination or defect in the drug itself.
Plain-English summary
Hospira Inc. is recalling 316,640 vials of Vancomycin Hydrochloride for Injection, USP. The affected product is sterile powder in 25 ml fliptop vials, packaged in 10-count trays, and is available by prescription only. The recall covers specific lots with expiration dates of 07/16 and 08/16.
The recall was initiated because the product trays containing the vials were mislabeled to indicate they contained a different product. This is a Class III recall, which the FDA defines as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not used until further notice.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 316,640
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 (6)
- Lot# 43-240-DD
- Exp. 07/16 Lot# 44-205-DD
- 44-455-DD
- 44-460-DD
- 44-465-DD
- Exp. 08/16
Distribution
Distributed nationwide across the United States.
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