The Recall Desk
SevereFDA (Drugs)·D-0295-2022·Announced 2022-01-05

Lidocaine Hydrochloride Topical Solution recalled for being superpotent

Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.

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: The FDA classified this recall as Class I, which per the rubric mandates a minimum score of 4. The hazard involves a superpotent drug that could result in overdose or serious adverse effects in patients receiving topical treatment.

Plain-English summary

Teligent Pharma, Inc., located in Buena, NJ, has initiated a voluntary recall of Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles. The affected product has NDC 63739-997-64 and was manufactured by Teligent Pharma, Inc. and distributed by McKesson Corporation dba Sky Packaging.

The recall was initiated due to the product being superpotent. A total of 6,816 bottles have been affected. Lot #16345 with expiration date 01/2024 is involved in this recall.

The product was distributed to a wholesaler in Colorado, which further distributed it nationwide throughout the United States. The FDA classified this as a Class I recall on December 28, 2021, and the firm initiated the recall on November 30, 2021.

Patients who have received this medication should consult with their healthcare provider about their treatment. Healthcare providers and consumers in possession of affected product should contact their pharmacy or healthcare supplier for instructions on return or disposal.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Solution
Hazard
Affected units
6,816

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 #: 16345
  • Exp. Date 01/2024

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Teligent Pharma, Inc. 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 2 products in this recall →

Related recalls

Same brand · LIDOCAINE HYDROCHLORIDE

Same manufacturer · Teligent Pharma, Inc.

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Same hazard · superpotency

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