Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,…

Recall date

August 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1046-2018

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide within the USA

Why it was recalled

Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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