The Recall Desk
ModerateFDA (Drugs)·D-1221-2015·Announced 2015-07-15

American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations

American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.

What this means for you

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 recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The specific deviation is a documentation/investigation failure (CGMP) rather than a direct physical hazard like contamination or mislabeling, fitting the 'Moderate' criteria for minor labeling or documentation issues.

Plain-English summary

American Health Packaging is recalling 2,558 cartons of Azithromycin tablets, USP 500mg. The affected product is packaged in 10-count blisters (NDC 68084-279-11) with 3 blister packs per carton (NDC 68084-279-21). The medication is prescription-only and was manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots are 134419A (Exp 12/31/2015), 193441B (Exp 02/29/2016), and 133684B (Exp 09/30/2015). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If found, the product should be returned to the distributor or disposed of according to local regulations. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
Manufacturer
American Health Packaging
Category
Drug — Antibiotic
Hazard
Affected units
2,558

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 (6)

  • Lot#: 134419A
  • Exp 12/31/2015
  • Lot#: 193441B
  • Exp 02/29/2016
  • Lot#: 133684B
  • Exp 09/30/2015.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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