Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Cidofovir Injection 375mg/5mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
23155-0216-31
Compare with the code on your package — it is the most precise check available.
Drug: Cidofovir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cidofovir Dihydrate NDC 23155-0216 |
CIDOFOVIR 375 mg/5mL | Injection, Solution Intravenous |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Rx |
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- NDC code
- 23155-0216-31
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0352-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cidofovir recalls
See all
Class II · Moderate risk
Cidofovir injection 375 mg/mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class II · Moderate risk
Cidofovir Dihydrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cidofovir Anhydrous active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cidofovir Opthalmic Solution
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Other recalls by Heritage Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
Clindamycin Palmitate Hydrochloride for Oral Solution
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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