Heritage Pharmaceuticals Recalls Cidofovir Dihydrate Injection Due to Sterility Concerns
Heritage Pharmaceuticals is recalling Cidofovir Dihydrate Injection due to complaints of dried powder on the outside of the bottle, which raises concerns about the product's sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling 2,789 units of Cidofovir Dihydrate Injection, 375 mg/mL (75 mg/mL) vials. The product is distributed nationwide within the United States. The specific lot affected is VCIA083, with an expiration date of JUN2020. The product is manufactured by Emcure Pharmaceutical Ltd in India for Heritage Pharmaceuticals, Inc.
The recall was initiated due to a lack of assurance of sterility. The company received complaints regarding dried powder found on the outside of the bottle. This condition suggests a potential breach in the product's sterility controls.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The product is a prescription-only medication intended for intravenous use.
The recalled product
- Product
- CIDOFOVIR DIHYDRATE (CIDOFOVIR DIHYDRATE)
- Brand
- CIDOFOVIR DIHYDRATE
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 2,789
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 #: VCIA083
- Exp. JUN2020
UPCs (1)
- 0323155216318
Distribution
Distributed nationwide across the United States.
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