The Recall Desk
ModerateFDA (Drugs)·D-1110-2015·Announced 2015-06-03

Blenheim Pharmacal Recalls Clarithromycin Tablets Due to cGMP Deviations

Blenheim Pharmacal is recalling 50 bottles of Clarithromycin Tablets 500 mg in Indiana due to cGMP deviations and inadequate complaint investigation.

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 and involves cGMP deviations regarding complaint investigation without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Blenheim Pharmacal, Inc. is recalling 50 bottles of Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only. The product is distributed by Wockhardt USA LLC and repackaged by Blenheim Pharmacal, Inc. The specific lot number is BP18181301 with an expiration date of 02/29/2016. The NDC is 10544-522-20 and the MFG code is 64679-904-02.

The recall is being conducted in response to a recall notice from the manufacturer, Wockhardt Limited, following an FDA inspection. The inspection noted cGMP deviations, specifically inadequate investigation of market complaints. This resulted in the unsuccessful identification of root causes and a failure to expand the investigation to prevent repeat failures.

The affected product was distributed in Indiana. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
Manufacturer
Blenheim Pharmacal, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
50

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 BP18181301
  • Exp. Date 02/29/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Blenheim Pharmacal, Inc. 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 2 products in this recall →

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