Drug 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
D-0846-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 89993
- Status
- Terminated
- Classification
- Class III
- Quantity
- 66,744 bottles
- Official record key
drug-enforcement:D-0846-2022
Official wording
Reason: Failed viscosity specification - product was below specificcation
Code information: Lot #: 370978, Exp 9/30/2022
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Unknown
Failed viscosity specification - product was below specificcation