AuroMedics Pharma LLC: Drug Recall
Recall #D-0013-2023 · 09/26/2022
Class II: Risk
Recall Details
- Recall Number
- D-0013-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- AuroMedics Pharma LLC
- Status
- Completed
- Date Initiated
- 09/26/2022
- Location
- East Windsor, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89400 vials
Reason for Recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by AuroMedics Pharma LLC
- Class II: Risk 09/30/2022
- Class III: Low Risk 09/26/2022
- Class I: Dangerous 01/26/2022
- Class II: Risk 12/30/2020
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.