Agency classClass IIOur severity:High FDA (Drugs)·D-0794-2022·Announced 2022-05-04

FDA Recalls Lidocaine-Prilocaine Topical Cream for Manufacturing Practice Violations

Teva Pharmaceuticals initiated a voluntary recall of Lidocaine-Prilocaine Cream due to manufacturing practice violations. The recall affects 353,964 units distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II pharmaceutical recall due to manufacturing practice deviations, indicating a reasonable probability of adverse health consequences. No illnesses or injuries have been reported.

Plain-English summary

Teva Pharmaceuticals USA Inc has recalled Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, due to violations in current Good Manufacturing Practice (cGMP) standards. The recall covers 353,964 units packaged in 5-gram and 30-gram tubes and distributed nationwide within the United States.

The product was originally manufactured by Teligent Pharma, Inc. (Buena, NJ) and distributed by Actavis Pharma, Inc. (Parsippany, NJ). The recall covers multiple lot numbers with expiration dates ranging from November 2022 through April 2024. The FDA classified this as a Class II recall, and the firm initiated the recall on April 15, 2022.

Healthcare providers and patients currently using or in possession of the affected product should contact their pharmacist or healthcare provider for guidance. The affected product carries the following NDC codes: 0591-2070-72 (5-gram tubes) and 0591-2070-30 (30-gram tubes).

The recalled product

Product: Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
Manufacturer: Teva Pharmaceuticals USA Inc
Category: Drug — Topical anesthetic
Hazard: manufacturing-deviation
Affected units: 353,964

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 (19)

Lot #: a) 16291
Exp. Date 01/2024
16469
Exp. Date 02/2024
b)16255
Exp. Date 11/2022
16256
16412 Exp. Date 02/2024
16257
16258
Exp. Date12/2022
16505
6506
Exp. Date 03/2024
16627
16786
16787
16820
Exp. Date 04/2024.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teva Pharmaceuticals USA Inc

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