FDA Recalls Lidocaine Prilocaine Cream Due to Manufacturing Compliance Issue
McKesson Corporation has recalled Lidocaine Prilocaine Cream 2.5%/2.5% because the manufacturer, Teligent Pharma, Inc., discontinued its stability study program, a deviation from manufacturing standards.
What this means for you
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 an FDA Class II recall with no reported illnesses or injuries. The discontinuation of the stability study program is a manufacturing compliance deviation that creates a theoretical risk regarding product quality and safety verification, but no actual harm has been documented.
Plain-English summary
Lidocaine Prilocaine Cream USP 2.5%/2.5% has been recalled. The affected product is supplied in 30-gram tubes under Lot 16876 with expiration date 05/31/2023, manufactured by Teligent Pharma, Inc., and distributed by McKesson Corporation. Approximately 1,176 tubes were distributed nationwide, including to Guam and the Northern Mariana Islands.
The recall was issued because the manufacturer discontinued its stability study program. The company's discontinuation of this program constitutes a deviation from Current Good Manufacturing Practice (CGMP). Stability studies are required to ensure that the product maintains its labeled strength and safety throughout its intended shelf life.
The FDA classified this as a Class II recall. Patients and healthcare providers who have received this product should contact McKesson Corporation or their pharmaceutical distributor for guidance on appropriate actions.
The recalled product
- Product
- Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
- Manufacturer
- McKesson Corporation dba McKesson Drug Company
- Category
- Drug — Topical Anesthetic
- Hazard
- cgmp-deviation
- stability-verification-gap
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: 16876
- Exp.: 05/31/2023
Distribution
Distributed nationwide across the United States.
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