Reported Jan 25, 2023 · Ongoing
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b)…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278
Is this the product you have?
- 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 byAkorn, Inc., Lake Forest, Il 60045
- Lot codes and dates
- Lot
140 of 140 codes
(a) 0A02B0A02D0A02C0A02A0A02EEXP 12/31/20220B60C0B46B0B60D EXP 1/31/20230B67B0B67D0B60B0B60A0B67A0B46D0B67C0B46AEXP 1/31/20230C78B0C78D0C78CEXP 2/28/20230D11A0D11C0D11B0D11DEXP 3/31/2023 0E35C0E35B0E35AEXP 4/30/20230J63B0J63CEXP 8/31/20230K02A0K02C0K02D0K02BEXP 9/30/20230L47B0L47C0L47AEXP 10/31/20231B12B1B12A1B23A1B23F1B12C1B23B1B23D1B23E1B12DEXP 1/31/20241C66C1C66AEXP 2/29/20241D93B1D93D1D93C1D99B1D99C
- Lot
- Amount recalled
- 2,369,258 tubes
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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