The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1224-2015·Announced 2015-07-15

American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations

American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific deviation is a documentation/investigation failure (CGMP) rather than a confirmed contamination or defect causing harm, aligning with the 'Moderate' criteria for minor labeling/documentation issues or voluntary precautionary recalls.

Plain-English summary

American Health Packaging is voluntarily recalling 3,572 cartons of Clarithromycin tablets, USP 500mg. The product is packaged in 10-count blisters (NDC 68084-437-11) with 5 blister packs per carton (NDC 68084-279-65). The tablets are manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ, for American Health Packaging in Columbus, OH.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots are 132323 (Exp 07/31/2015), 132960 (Exp 09/30/2015), 133707A (Exp 10/31/2015), and 133707B (Exp 11/30/2015). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Manufacturer
American Health Packaging
Category
Drug — Antibiotic
Hazard
Affected units
3,572

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 (8)

  • Lot#: 132323
  • Exp 07/31/2015
  • Lot#: 132960
  • Exp 09/30/2015
  • Lot#: 133707A
  • Exp 10/31/2015
  • Lot#: 133707B
  • Exp 11/30/2015.

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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