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

FDA recall notice · announced May 11, 2022 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed viscosity specification - product was below specificcation

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot #: 370978, Exp 9/30/2022
Quantity: 66,744 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0846-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.