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.
What this means for you
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
- 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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