Injectable Acyclovir Sodium Recalled for Particulate Matter Contamination
Eugia US LLC is recalling Acyclovir Sodium Injection (45,250 vials) distributed nationwide due to the presence of dark particles found inside vials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving particulate contamination in a parenteral (injectable) drug. While no illnesses or injuries have been reported, particulate matter in an intravenous injection poses a potential risk of harm if administered. The classification aligns with the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Eugia US LLC, in coordination with the U.S. Food and Drug Administration, is recalling Acyclovir Sodium Injection, 1,000 mg per 20 mL vials, distributed nationwide. The recall affects 45,250 vials from Lot AC22004 with an expiration date of August 2023. The product is distributed by AuroMedics Pharma LLC.
The recall was initiated following a customer complaint regarding the presence of dark particles found inside vials. Particulate matter in an injectable pharmaceutical may affect product safety and integrity if administered to patients.
Healthcare providers and patients who may have received product from the affected lot should not administer remaining doses. Patients should contact their healthcare provider if they have questions about their treatment. Unused product should be returned to the pharmacy or distributor.
The recalled product
- Product
- ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
- Brand
- ACYCLOVIR SODIUM
- Manufacturer
- Eugia US LLC
- Category
- Drug
- Hazard
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AC22004
- Expiry: 08/2023
UPCs (2)
- 0355150155200
- 0355150154104
Distribution
Distributed nationwide across the United States.
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