FDA-Drug2022-05-11Class III

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Akorn, Inc.
Hazard

Failed viscosity specification - product was below specificcation

Sold states
Nationwide USA and Puerto Rico
Affected count
66,744 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0846-2022

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