PharMEDium Lidocaine Syringes Recalled for Potential Loss of Potency
PharMEDium is recalling lidocaine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug 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 theoretical loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
PharMEDium Services, LLC is recalling 6,324 syringes of lidocaine HCl, 2%, 40 mg per 2 mL. The product is prescription-only and was distributed nationwide. 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 the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.
Healthcare providers and patients should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 6,324
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 (14)
- Lot Numbers: 15118067M
- 15120045M
- 15127005M
- 15131002M
- 15135005M
- 15135046M
- 15140001M
- 15140045M
- 15146007M
- 15147070M
- 15152052M
- 151880331M
- 151900241M
- 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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