Drug product
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.
D-0013-2023
Product summary
- Event
- Event 90896
- Status
- Completed
- Classification
- Class II
- Quantity
- 89400 vials
- Official record key
drug-enforcement:D-0013-2023
Official wording
Reason: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Code information: Lot: AC22006, Exp 08/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter