The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1268-2015·Announced 2015-07-29

Wockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations

Wockhardt USA is recalling 16,276 bottles of 15 mg Lansoprazole Delayed-Release Capsules 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 and involves a procedural CGMP deviation (failure to investigate complaints) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk or voluntary precautionary issues.

Plain-English summary

Wockhardt USA LLC is recalling 16,276 bottles of Lansoprazole Delayed-Release Capsules, USP, 15 mg. The product is packaged in 30-count bottles and is available by prescription only. The specific lot number is LN11008, with an expiration date of 4/30/2015.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The product was distributed nationwide in the United States, including Puerto Rico.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
16,276

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 #: LN11008
  • Expiry: 4/30/2015.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa 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 35 products in this recall →

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