Reported May 10, 2017 · Terminated
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada,…
The Harvard Drug Group
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951
Is this the product you have?
- 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
- Lot codes and dates
- LOTT-00601
- Exp04-2017
- Amount recalled
- 36,990 tablets
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Superpotent Drug; out of specification results for assay (manufacturer)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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