FDA Drug recall D-1248-2019
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 ND…
- FDA Drug
- Class I
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class I recall of 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 ND… by Aurobindo Pharma Usa, citing presence of Particulate Matter: One vial was found to contain a hair.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1248-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-28 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | NC, NM |
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
Reason
Presence of Particulate Matter: One vial was found to contain a hair.
Identifiers
| ndc | 76420-782-01 |
|---|---|
| ndc | 0517-0720-01 |
| ndc | 55150-162-05 |
| ndc | 0409-1159-18 |
| ndc | 67777-419-02 |
| code_info | Lot #: CLC180117, Exp. June 2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1248-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.