Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1219-2015·Announced 2015-07-15

Amlodipine besylate tablets recalled for inadequate complaint investigation

American Health Packaging is recalling Amlodipine besylate tablets 5mg due to CGMP deviations involving inadequate investigation of 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 due to CGMP deviations (inadequate complaint investigation) without reported illnesses or injuries, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity score.

Plain-English summary

American Health Packaging is voluntarily recalling Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters. The recall involves 20,855 cartons distributed nationwide. The affected product is identified by Lot numbers 131954 and 131955, with an expiration date of 08/31/2015. The product is manufactured by Wockhardt Limited, Mumbai, India, and distributed by Wockhardt, USA, LLC.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This classification is designated as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and return it to the point of purchase or contact the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA…
Manufacturer: American Health Packaging
Category: Drug — Tablets
Hazard: cgmp-deviation
quality-control
Affected units: 20,855

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 (3)

Lot#: 131954
131955
Exp 08/31/2015

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 →

Same manufacturer · American Health Packaging

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