Home / Recalls / Akorn, Inc. / D-1046-2018

D-1046-2018 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-1046-2018 was initiated by Akorn, Inc. on Aug 1, 2018 and is designated Class II. Reason for recall: Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months. The recall status is terminated (terminated Nov 6, 2020). Affected quantity: 22,605 tubes.

Recall Details

Product Type: Drugs
Report Date: Aug 15, 2018
Initiation Date: Aug 1, 2018
Termination Date: Nov 6, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,605 tubes

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide within the USA

Code Information

Lot #: 356309, Exp. 3/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1046-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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