Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns
Hospira is recalling 187,150 vials of Bupivacaine Hydrochloride with Epinephrine due to a lack of assurance of sterility and potential vial breakage.
What this means for you
Illness, injury, or structural failure has been reported. 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 serious injury or adverse health consequences.
Plain-English summary
Hospira, Inc. is recalling 187,150 vials of 0.5% Bupivacaine Hydrochloride and Epinephrine 1:200,000 Injection, 10 mL, Single-Dose Vial (NDC 0409-9045-01). The recall is being conducted due to a lack of assurance of sterility and the potential for vial breakage.
The affected product is identified by Lot 17-400-EV* and 17-401-EV*, noting that the lot number may be followed by 01. The product was distributed nationwide, as well as to Guam and Abu Dhabi.
Healthcare providers and patients should stop using the affected vials and contact Hospira, Inc. for further instructions or a replacement. This recall is classified as FDA Class II.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 187,150
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 (1)
- Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Distribution
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