Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
Reported: October 26, 2022 Initiated: September 26, 2022 #D-0013-2023
Product Description
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
Reason for Recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 89400 vials
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.. Recalled by AuroMedics Pharma LLC. Units affected: 89400 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 26, 2022. Severity: Moderate. Recall number: D-0013-2023.
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