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
Reported: May 10, 2017 Initiated: December 27, 2016 #D-0692-2017
Product Description
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
Reason for Recall
Superpotent Drug; out of specification results for assay (manufacturer)
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 36,990 tablets
- Distribution
- Nationwide and PR
- Location
- Livonia, MI
Frequently Asked Questions
What product 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. Recalled by The Harvard Drug Group. Units affected: 36,990 tablets.
Why was this product recalled? ▼
Superpotent Drug; out of specification results for assay (manufacturer)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 10, 2017. Severity: Low. Recall number: D-0692-2017.
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