The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1046-2018·Announced 2018-08-15

Akorn Recalls Lidocaine and Prilocaine Cream Due to Impurity

Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream, 2.5%, 30g tubes. The product is prescription-only and was manufactured by Hi-Tech Pharmacal Co., Inc. in Amityville, NY. The recall involves 22,605 tubes with Lot # 356309 and an expiration date of 3/2019. The product was distributed nationwide within the USA.

The recall was initiated because out-of-specification results for an unknown impurity were found during routine stability testing at 12 months. This is classified as an FDA Class II recall.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Manufacturer
Akorn, Inc.
Category
Drug — Topical Anesthetic
Hazard
Affected units
22,605

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 #: 356309
  • Exp. 3/2019

Distribution

Distributed nationwide across the United States.

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