Pharmedium Recalls Buffered Lidocaine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 660 syringes of Buffered Lidocaine because stability data does not support the expiry dates, posing a risk of potency loss.
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 is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is recalling 660 syringes of Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume. The product is a prescription-only local anesthetic identified by product code 2K2466. The recall involves specific lot numbers 15194041E, 15195008E, and 15195020E, with expiration dates ranging from July 15, 2015, to October 12, 2015.
The recall was initiated because stability data does not support the stated expiry dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. The affected products were distributed nationwide.
Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement. Consumers should verify the lot numbers and expiration dates on their packaging to determine if they are affected.
The recalled product
- Product
- Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Local Anesthetic
- Hazard
- Affected units
- 660
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)
- Lot Numbers: 15194041E
- 15195008E
- 15195020E
- 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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