American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling 2,068 cartons of Azithromycin tablets 250mg due to inadequate investigation of 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 due to CGMP deviations (inadequate complaint investigation) without reported illnesses or injuries, fitting the 'Moderate' criteria for minor labeling or process errors.
Plain-English summary
American Health Packaging is voluntarily recalling 2,068 cartons of Azithromycin tablets, USP 250mg, packaged in 10-count blisters. The product is distributed nationwide and is identified by Lot #134392 with an expiration date of 06/30/2015. The tablets are 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. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased this specific lot of Azithromycin tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Amer
- Manufacturer
- American Health Packaging
- Category
- Drug — Antibiotic
- Affected units
- 2,068
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 (2)
- Lot#: 134392
- Exp 06/30/2015
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.
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