Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 830 syringes of lidocaine HCl, 2%, preservative-free, because stability data does not support the expiry dates, posing a risk of potential 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 due to a potential loss of potency, which is a theoretical risk of reduced efficacy rather than a direct physical injury or contamination hazard, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 830 syringes of lidocaine HCl, 2%, preservative-free, total volume 2mL (Product code 2R3323, NDC 61553-323-79). The recall was initiated because stability data does not support the expiry dates for the product, which may result in a potential loss of potency in the drugs packaged and stored in syringes.
The affected product was distributed nationwide. The specific lot numbers involved are 15119047M, 15124043M, 151340072M, 15134037M, and 15148042M, with expiration dates ranging between 07/15/15 and 10/12/15.
Consumers and healthcare providers should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a refund. The U.S. Food and Drug Administration classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 830
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 Numbers: 15119047M
- 15124043M
- 151340072M
- 15134037M
- 15148042M
- 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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