Drug product
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
D-1248-2019
Product summary
- Event
- Event 82496
- Status
- Terminated
- Classification
- Class I
- Quantity
- 88600 vials
- Official record key
drug-enforcement:D-1248-2019
Official wording
Reason: Presence of Particulate Matter: One vial was found to contain a hair.
Code information: Lot #: CLC180117, Exp. June 2021
Distribution pattern: Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter