Lidocaine Hydrochloride Jelly Recalled for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.
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: This is an FDA Class II voluntary, firm-initiated recall due to manufacturing quality deviations. This fits the rubric criterion of 'voluntary precautionary recalls' for a Moderate severity rating.
Plain-English summary
Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly USP, 2%. The affected product includes 5 mL tubes (NDC 17478-711-10) packaged 10 per box and 30 mL tubes (NDC 17478-711-30), distributed nationwide.
The recall is due to Current Good Manufacturing Practices (CGMP) deviations identified during manufacturing. Multiple lot codes are affected with expiration dates ranging from December 2022 through March 2025.
Consumers and healthcare providers should discontinue use of affected lots and verify their inventory against the recalled lot numbers and expiration dates provided by the FDA.
The recalled product
- Product
- Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- manufacturing-quality
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 (20)
- Lot: (a) 0A02B
- 0A02D
- 0A02C
- 0A02A
- 0A02E
- EXP 12/31/2022
- 0B60C
- 0B46B
- 0B60D EXP 1/31/2023
- 0B67B
- 0B67D
- 0B60B
- 0B60A
- 0B67A
- 0B46D
- 0B67C
- 0B46A
- EXP 1/31/2023
- 0C78B
- 0C78D
Distribution
Distributed nationwide across the United States.
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