Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0595-2018·Announced 2018-02-21

Aripiprazole Tablets Recalled Due to CGMP Deviations and API Specification Failures

American Health Packaging is recalling 270 cartons of Aripiprazole Tablets, USP, 10 mg, because the active pharmaceutical ingredient did not meet all intended specifications.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of substandard API, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Health Packaging is voluntarily recalling 270 cartons of Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters. The affected product is identified by Lot # 174096 and an expiration date of 05/31/19. The product is distributed nationwide in the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the lot was manufactured using an active pharmaceutical ingredient (API) that did not meet all of its intended specifications. This classification is designated as FDA Class II.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The recall is limited to the specific lot and expiration date listed above.

The recalled product

Product: ARIPIPRAZOLE (ARIPIPRAZOLE)
Brand: ARIPIPRAZOLE
Manufacturer: AMERICAN HEALTH PACKAGING
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
api-specification-failure
Affected units: 270

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 #: 174096
Exp 05/31/19

UPCs (1)

003606871791

Distribution

Distributed nationwide across the United States.

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