Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Reported: December 18, 2019 Initiated: November 25, 2019 #D-0574-2020
Product Description
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Reason for Recall
Discoloration: Product complaints of discoloration after reconstitution of vials.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 275,060 vials
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.. Recalled by AuroMedics Pharma LLC. Units affected: 275,060 vials.
Why was this product recalled? ▼
Discoloration: Product complaints of discoloration after reconstitution of vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0574-2020.
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