Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1226-2015·Announced 2015-07-15

American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

American Health Packaging is recalling 4,718 cartons of Lisinopril 5mg tablets due to 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 and involves CGMP deviations regarding complaint investigation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Health Packaging is recalling 4,718 cartons of Lisinopril tablets, USP 5mg. The product is packaged in 10-count blisters (NDC 68084-060-11) with 10 blister packs per carton (NDC 68084-060-01). The tablets are prescription-only and were manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lot number is 131928, with an expiration date of 09/30/2015. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should discontinue use of the affected product and contact their pharmacist or physician for guidance on alternative treatment options. The recall is classified as Class II by the FDA.

The recalled product

Product: Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American…
Manufacturer: American Health Packaging
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
Affected units: 4,718

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#: 131928
Exp 09/30/2015

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 →

Same manufacturer · American Health Packaging

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Same hazard · cgmp deviation