Agency classClass IIOur severity:Moderate FDA (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.

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 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: cGMP-deviation
quality-control
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 →

Same manufacturer · Blenheim Pharmacal, Inc.

See all →

Moderate
Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations
FDA (Drugs) · 2015-06-03

Same hazard · cGMP deviation