The Recall Desk
ModerateFDA (Drugs)·D-0064-2017·Announced 2016-10-19

Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 300 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a 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 and involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling or stability issues.

Plain-English summary

Pharmedium Services, LLC is recalling 300 syringes of lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, Product code 2R3391. The recall is due to stability data that does not support the expiry date, which may result in a potential loss of potency in the drug.

The affected product is identified by Lot Number 15113065M with expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide. This is a prescription-only medication.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Local Anesthetic
Hazard
Affected units
300

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: 15113065M
  • 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.

See all 69 products in this recall →

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