Recalls / Class II
Class IID-0013-2023
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.
- Brand name
- Acyclovir Sodium
- Generic name
- Acyclovir Sodium
- Active ingredient
- Acyclovir Sodium
- Route
- Intravenous
- NDCs
- 55150-154, 55150-155
- FDA application
- ANDA203701
- Affected lot / code info
- Lot: AC22006, Exp 08/2023
Why it was recalled
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 89400 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-26
- FDA classified
- 2022-10-18
- Posted by FDA
- 2022-10-26
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0013-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.