PharMEDium Recalls Bupivacaine Bags Due to Human Hair Particulate Matter
PharMEDium Services is recalling 20 bags of Bupivacaine HCl 0.0625% for epidural use because they contain human hair particulate matter.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
PharMEDium Services, LLC is recalling 20 bags of Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only. The product is identified by NDC# 61553-197-50 and was distributed nationwide.
The recall was initiated because the firm manufactured the products using Hospira 0.9% Sodium Chloride, USP injection, which was subsequently recalled due to the presence of particulate matter, specifically human hair. The affected lots are 143140080M (Exp 02/09/15), 143210133M (Exp 02/16/15), and 143490031M (Exp 03/16/15).
Healthcare providers and patients should stop using the affected product and contact PharMEDium Services, LLC for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Affected units
- 20
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 #: 143140080M
- Exp 02/09/15
- 143210133M
- Exp 02/16/15
- 143490031M
- Exp 03/16/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Pharmedium Services, LLC 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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