Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or hospitalizations. The hazard (incomplete stability studies due to firm closure) is precautionary and compliance-related rather than indicative of known patient harm.
Plain-English summary
Akorn, Inc. is recalling all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes, Rx Only), manufactured for HI-TECH PHARMACAL CO., INC. The recall affects products distributed nationwide in the USA and Puerto Rico.
The reason for the recall is CGMP (Current Good Manufacturing Practice) deviations. The firm went out of business and could no longer continue the stability studies required by FDA regulations. Stability studies are critical to ensure that a pharmaceutical product maintains its strength, quality, and purity throughout its shelf life.
Patients currently using this product should consult with their healthcare provider about continuing use or obtaining an alternative. Dispensed and distributed units remain subject to return or destruction as directed by the FDA.
The recalled product
- Product
- Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Local Anesthetic
- Hazard
- cgmp-deviation
- stability-data-missing
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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