The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-745-2014·Announced 2014-01-22

Pfizer Recalls Zithromax Injection Lots for Impurity Specification Failures

Pfizer is recalling specific lots of Zithromax (azithromycin) injection due to out-of-specification results for a degradant.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates a remote possibility of adverse health consequences. The issue is a chemical impurity (degradant) rather than a high-risk pathogen or structural defect, and no injuries or illnesses are reported in the source text.

Plain-English summary

Pfizer Inc. is recalling certain lots of Zithromax (azithromycin dihydrate) for injection, 500 mg/vial. The recall involves 101,681 vials distributed nationwide and in Puerto Rico. The affected lots are identified by specific lot numbers and expiration dates, including G81845, 0B0CJ, G44710, G65241, G80003, G82722, G93028, G95309, and G97641.

The recall was initiated because the product failed impurities and degradation specifications. Specifically, the lots showed out-of-specification results for the azithromycin N-oxide degradant. This is a chemical byproduct that can form during the degradation of the active ingredient.

Healthcare providers and patients should check their inventory of Zithromax for injection against the listed lot numbers and expiration dates. If the product matches the recalled lots, it should not be used. Consumers and healthcare professionals should contact Pfizer or their local FDA office for further instructions on how to return or dispose of the affected medication.

The recalled product

Product
ZITHROMAX (AZITHROMYCIN DIHYDRATE)
Brand
ZITHROMAX
Manufacturer
Pfizer Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
101,681

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 (10)

  • Lot Number/Expiration Date G81845
  • Exp 10/03/14 0B0CJ
  • Exp 02/06/15 G44710
  • Exp 07/10/15 G65241
  • Exp 07/11/15 G80003
  • Exp 10/17/15 G82722
  • Exp 11/27/15 G93028
  • G95309
  • Exp: 01/23/16 G97641
  • Exp 01/30/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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