Akorn Recalls Lidocaine Hydrochloride Jelly Due to Metal Particulate Finding
Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2% due to a finding of metal particulate matter in the filling room. No particulates were identified in the product itself.
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: The recall is classified as FDA Class II. The hazard is a cGMP deviation involving metal particulates found on the filling line, with no particulates identified in the product itself and no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2%, 30 mL tubes (NDC 17478-711-30). The recall involves 10,543 tubes from Lot 9B21A, with an expiration date of 1/2022. The product was distributed nationwide within the United States and Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. The firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation. The source text explicitly states that no particulates were identified in the product, but rather were identified on the filling line.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The product is prescription-only (Rx Only) and sterile.
The recalled product
- Product
- Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Anesthetic
- Affected units
- 10,543
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 #: 9B21A
- Exp. 1/2022
Distribution
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