Apotex Scientific, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontari…
- Recall date
- January 26, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1437-2016
- FDA classification
- Class III
- Brand / firm
- Apotex Scientific, Inc
- Sold / distributed
- Nationwide, Alaska, Hawaii, and Puerto Rico.
Why it was recalled
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
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