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.
Reported: January 25, 2023 Initiated: October 13, 2022 #D-0143-2023
Product Description
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.
Reason for Recall
CGMP Deviations:
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 2,369,258 tubes
- Distribution
- Nationwide in the USA
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 2,369,258 tubes.
Why was this product recalled? ▼
CGMP Deviations:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0143-2023.
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