FDA Recalls Lidocaine-Prilocaine Topical Cream for Manufacturing Practice Violations

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.

Distribution

Related recalls