Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Reported: December 4, 2019 Initiated: November 11, 2019 #D-0573-2020
Product Description
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Reason for Recall
Presence of Foreign Substance: Foreign material found inside the vial.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 111,850 vials
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.. Recalled by AuroMedics Pharma LLC. Units affected: 111,850 vials.
Why was this product recalled? ▼
Presence of Foreign Substance: Foreign material found inside the vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 4, 2019. Severity: Moderate. Recall number: D-0573-2020.
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