Class II · Moderate risk
Azithromycin for Injection USP Vial
cGMP deviations: Temperature abuse
Zithromax (azithromycin for injection) (Azithromycin Dihydrate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84
Affected NDC
0069-3150-84
Compare with the code on your package — it is the most precise check available.
Drug: Azithromycin Category: Antibiotic
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 |
|---|---|---|---|---|
| Zithromax azithromycin dihydrate NDC 00069-3150 |
500 mg/5mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Pfizer Laboratories Div Pfizer Inc | Rx |
- Recalling firm
- Pfizer Inc.
- NDC code
- 0069-3150-84
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-745-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Azithromycin recalls
See all
Class II · Moderate risk
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Other recalls by Pfizer Inc.
All 2014 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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