Lidocaine Hydrochloride Jelly Recalled Due to cGMP Deviations and Turbidity
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with confirmed turbidity in a sterile pharmaceutical product. Although no illnesses or injuries have been reported, the cGMP deviation and potential loss of sterility in a product intended for medical use presents a risk of harm.
Plain-English summary
Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2%, a sterile topical anesthetic in 30mL tubes, due to current Good Manufacturing Practice (cGMP) deviations. During sterility testing, turbidity was discovered, indicating a potential manufacturing control issue.
The recall affects 82,689 tubes distributed nationwide under multiple lot numbers, with expiration dates ranging from 8/31/2022 to 11/30/2022. The scope of the recall has been expanded to potentially include other products manufactured by Akorn that may share the same root cause.
Patients and healthcare providers should stop using affected lots immediately. Product should be disposed of according to local regulations or returned to the distributor. Any persons who have used this product should consult their healthcare provider if they have questions or concerns.
The recalled product
- Product
- Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- turbidity
- sterility-defect
- manufacturing-deviation
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 (17)
- Lot # 9J36A
- 9J36B
- 9J39A
- 9J39B
- 9J39C
- 9J39D
- 9J39E
- 9J42B
- 9J42C
- Exp 8/31/2022
- 9K62A
- 9K62B
- 9K62C
- Exp 9/30/2022
- 9M04A
- 9M04B
- Exp 11/30/2022
Distribution
Distributed nationwide across the United States.
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