D-1248-2019 Class I Terminated
FDA drug recall D-1248-2019 was initiated by Aurobindo Pharma USA Inc. on March 28, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter: One vial was found to contain a hair. The recall status is terminated (terminated April 11, 2024). Affected quantity: 88600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 28, 2019
- Termination Date
- April 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88600 vials
Product Description
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
Reason for Recall
Presence of Particulate Matter: One vial was found to contain a hair.
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.
Code Information
Lot #: CLC180117, Exp. June 2021