The Recall Desk
SevereFDA (Drugs)·D-0101-2024·Announced 2023-11-15

Lidocaine injection recalled due to glass particulate matter

Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% injection due to presence of glass particulate matter. Lot 42290DK with expiration 6/1/2024 is affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification for an injectable drug with identified glass particulate contamination meets the threshold for Severe severity. Although no illnesses or injuries have been reported in the source text, the concrete identification of a foreign particulate hazard in an intravenous injection presents serious risk of harm.

Plain-English summary

Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% Injection, USP (50mg/5mL), distributed as single-use glass syringes. The recalled product is lot number 42290DK with an expiration date of 6/1/2024.

The recall is initiated due to the presence of glass particulate matter identified in the product. This intravenous anesthetic injection was distributed nationwide throughout the United States and Puerto Rico, but was not distributed to government accounts or foreign consignees.

Healthcare providers and patients currently using this product should discontinue use immediately and consult with their healthcare provider. The affected lot can be identified by lot number 42290DK on the vial label.

This FDA Class I recall indicates a potentially serious health hazard. Persons experiencing adverse events related to this product should report them to the FDA's MedWatch program or contact Pfizer Inc. directly.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Pfizer Inc.
Hazard
  • glass-particulate-matter

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#: 42290DK
  • Exp. 6/1/2024

Distribution

Distributed nationwide across the United States.