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
Reported: April 17, 2019 Initiated: March 28, 2019 #D-1248-2019
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.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 88600 vials
- Distribution
- 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.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 88600 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: One vial was found to contain a hair.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Critical. Recall number: D-1248-2019.
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