Antipsychotic Drug Recalled for Failed Quality Control Test
Ascend Laboratories is recalling 135 bottles of Aripiprazole 20 mg tablets nationwide due to failure of spectroscopic identification testing, indicating the product may not meet established quality standards.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a prescription medication that failed critical identity testing (spectroscopic identification). While no illnesses or injuries have been reported, a drug that cannot be verified to meet identity specifications represents a risk-of-harm product, warranting a High severity rating.
Plain-English summary
Ascend Laboratories, LLC is recalling 135 bottles of Aripiprazole 20 mg tablets distributed nationwide. The recall was initiated because the product failed spectroscopic identification testing by infrared (IR) analysis, meaning the tablets do not meet established quality and identity specifications.
Aripiprazole is a prescription antipsychotic medication. When a drug fails identity testing, it indicates uncertainty about the product's chemical composition and purity, raising concerns about whether the medication is correctly formulated and safe to use.
The affected lot is #22143120 with an expiration date of June 2024. If you have Aripiprazole tablets from this lot, do not use them. Contact your pharmacy or healthcare provider immediately for guidance on obtaining a replacement prescription.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Antipsychotic
- Affected units
- 135
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 #22143120
- Exp. Date: June 2024
Distribution
Distributed nationwide across the United States.
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