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.
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 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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