Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations
Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Hetero Labs, Ltd. is recalling 3,000 bottles of Aripiprazole Tablets, USP, 10 mg. The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. The specific lots affected are ARI17089 and ARI17090, with an expiration date of 5/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the lots were made with an active pharmaceutical ingredient that did not meet all its intended specifications. The distribution was limited to New Jersey.
Consumers who have these specific lots of Aripiprazole tablets should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Prescription Medication
- Affected units
- 3,000
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 #: ARI17089
- ARI17090
- Exp. 5/2019
UPCs (2)
- 0331722828055
- 0331722820301
Distribution
Distributed in 1 state:
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