Pharmedium Recalls Buffered Lidocaine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 10 syringes of Buffered Lidocaine 2% because stability data does not support the expiry date, posing a risk of loss of potency.
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 10 syringes of Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe (Product code 2K2475). The recall is being conducted because stability data does not support the expiry date for the product, which may result in a potential loss of potency in drugs packaged and stored in syringes.
The affected product is identified by Lot Number 15195070E and has an expiration date between 07/15/15 and 10/12/15. The product was distributed nationwide. This is a prescription-only medication intended for local anesthetic use.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Local Anesthetic
- Hazard
- Affected units
- 10
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 (2)
- Lot Number: 15195070E
- 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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