The Recall Desk
ModerateFDA (Drugs)·D-0092-2017·Announced 2016-10-19

PharMEDium Recalls Lidocaine Syringes Due to Stability Data Concerns

PharMEDium is recalling 499 syringes of lidocaine HCl 2% 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 voluntary precautionary recall.

Plain-English summary

PharMEDium Services, LLC is recalling 499 syringes of lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, Product code 2R3110. 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 the drugs packaged and stored in syringes.

The affected product is identified by Lot Number 15112122M with expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class II.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions or a replacement.

The recalled product

Product
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
499

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: 15112122M
  • 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 →

Related recalls

Same manufacturer · Pharmedium Services, LLC

See all →

Same hazard · loss of potency

See all →