October 2018 FDA Recall Cidofovir Dihydrate by Heritage Pharmaceuticals, Inc.
D-0094-2019 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals, Inc. on October 15, 2018 for the product Cidofovir Dihydrate. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0094-2019

Reason for Recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Initiated
10-15-2018
Reported
10-31-2018
Quantity
2,789 Units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81276
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Heritage Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2023
Product Description About Product Description
Full technical description of the product.
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

Batch or Lot Expiration Information

Lot# : VCIA083, Exp. JUN2020

Affected Packages Involved in this Recall

23155-216-31 Cidofovir Dihydrate