Hospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Abuse
Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection because they experienced uncontrolled temperature excursions during transit.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves temperature abuse which is a quality control issue rather than a direct contamination or structural defect causing immediate harm.
Plain-English summary
Hospira Inc. is recalling 200 vials of Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial. The recall is limited to Lot # 34-366-8E02 with an expiration date of 1OCT2015. The product is packaged in 10 units per carton and is available by prescription only.
The recall was initiated because the products experienced uncontrolled temperature excursions during transit. This temperature abuse may affect the stability and efficacy of the medication.
The affected lot was distributed in a single shipment to The Harvard Drug Group in Livonia, Michigan. The source text notes that these lots remained within the control of the distributor and were not further distributed. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should not be used and should be returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 200
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)
- One shipment of Lot #: 34-366-8E02
- Exp 1OCT2015 to The Harvard Drug Group
- Livonia
- MI
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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