Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 512 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a potential 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 involves 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 512 syringes of lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, Product code 2R3384. The recall is being conducted because stability data does not support the expiry date for the product.
The affected product is identified by Lot Numbers 15112074M and 15113030M, with expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide. The hazard associated with this recall is a potential loss of potency in the drugs packaged and stored in syringes.
Consumers and healthcare providers should stop using the affected product and contact Pharmedium Services, LLC for further instructions or a refund. This recall is classified as Class II by the FDA.
The recalled product
- Product
- lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 512
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 (3)
- Lot Numbers: 15112074M
- 15113030M
- 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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