The Recall Desk
LowFDA (Drugs)·D-0692-2017·Announced 2017-05-10

Aripiprazole Tablets Recalled for Out-of-Specification Assay Results

The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, due to out-of-specification assay results. The recall covers 36,990 tablets distributed nationwide and in Puerto Rico.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text explicitly identifies this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

The Harvard Drug Group is voluntarily recalling Aripiprazole Tablets, 2 mg, 30 count unit dose boxes. The product is manufactured by Apotex Inc. and distributed by Major Pharmaceuticals. The recall is limited to Lot T-00601 with an expiration date of 04-2017. The total quantity involved is 36,990 tablets.

The recall was initiated because the product failed to meet specification requirements for assay, a test that measures the amount of active ingredient in the drug. This is classified as a Class III recall by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed nationwide and in Puerto Rico. Patients and healthcare providers should discontinue use of the recalled lot and contact their pharmacist or prescriber for replacement or alternative treatment options.

The recalled product

Product
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Manufacturer
The Harvard Drug Group
Category
Drug — Prescription Medication
Hazard
Affected units
36,990

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 (1)

  • LOT: T-00601 Exp: 04-2017

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · The Harvard Drug Group

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Same hazard · assay failure

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