Heritage Pharmaceuticals Recalls Cidofovir Injection Due to Sterility Concerns
Heritage Pharmaceuticals is recalling Cidofovir Injection vials due to complaints about dried powder on the outside of the bottles, which raises concerns about 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' rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable drug.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling Cidofovir Injection 375mg/5mL vials. The recall is being conducted because of complaints received regarding dried powder found on the outside of the bottles. This issue raises a lack of assurance of sterility for the product.
The affected product is Cidofovir Injection 375mg/5mL (75mg/mL), available in 5 mL vials, and is prescription-only. The specific lots involved are VCIA082 (expiring May 2020), VCIA083, and VCIA084 (expiring June 2020). The product was manufactured by Emcure Pharmaceuticals Ltd. in India for Heritage Pharmaceuticals, Inc. A total of 5,060 units were distributed nationwide.
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations. Consumers should consult their healthcare provider if they have questions about the medication.
The recalled product
- Product
- Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Antiviral Injection
- Hazard
- Affected units
- 5,060
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 (5)
- Lot #: VCIA082
- Exp. MAY 2020
- VCIA083
- VCIA084
- Exp. JUNE 2020
Distribution
Distributed nationwide across the United States.
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