Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 210 syringes of Fentanyl Citrate and Bupivacaine HCl because stability data does not support the expiration dates, posing a risk of loss of potency.
What this means for you
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 is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmedium Services, LLC is recalling 210 syringes of Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride. The product is intended for epidural use and is available by prescription only. The recall involves specific lot numbers with expiration dates between July 15, 2015, and October 12, 2015.
The recall was initiated because stability data does not support the expiration dates for drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 210
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 (7)
- Lot Numbers: 151000045M
- 15127040M
- 15133026M
- 15141029M
- 151930078M
- 15132103M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 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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