The Harvard Drug Group recalls Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Dis…
- Recall date
- December 27, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0692-2017
- FDA classification
- Class III
- Brand / firm
- The Harvard Drug Group
- Sold / distributed
- Nationwide and PR
Why it was recalled
Superpotent Drug; out of specification results for assay (manufacturer)
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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