Apotex Recalls Aripiprazole Tablets Due to Potential Potency Issues
Apotex Inc. is recalling 67,946 bottles of 2 mg Aripiprazole tablets because the product may not meet specifications throughout its shelf life.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Inc. is recalling 67,946 bottles of Aripiprazole Tablets, 2 mg, 30-count, prescription only. The product is manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida. The specific lot number is MJ7746, with an expiration date of 04/17.
The recall was initiated because the product may not meet specifications throughout its shelf life, specifically regarding its potency. The agency has classified this as a Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement, as directed by the recalling firm.
The recalled product
- Product
- Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 67,946
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 #: MJ7746
- Exp 04/17
Distribution
Distributed nationwide across the United States.
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