CLASS II Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report
Cidofovir Injection 375mg/ (75mg/mL) vial injection recalled
Heritage Pharmaceuticals is recalling Cidofovir Injection 375mg/ (75mg/mL) vial injection, distributed nationwide in the US. The recall was initiated on 2 Jan 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0352-2019
- FDA event ID
- 81896
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 8 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 8 Jan 2019 | Classified by FDA | +6 days |
| 16 Jan 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Which lots are affected?
Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Cidofovir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection vials recalledCidofovir Dihydrate | Heritage Pharmaceuticals | Sterility | Nationwide |