Drug product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
D-0279-2022
Product summary
- Event
- Event 88850
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,008 glass bottles
- Official record key
drug-enforcement:D-0279-2022
Official wording
Reason: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Code information: Lot #: 16306, Exp. Date 01/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
superpotent