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Drug recall · FDA · Published January 26, 2016

Apotex Scientific, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto,

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

🇺🇸 FDA recall #D-1436-2016DrugApotex Scientific, Inc ›
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Contact the company & request your remedy

Recalling firmApotex Scientific, Inc2100 Rd To Six Flags Dr · Arlington, TX 76011
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/43209-apotex-scientific-inc-recalls-duloxetine-delayed-release-capsules-usp-60 · Recall date January 26, 2016 · FDA enforcement record: FDA #D-1436-2016

Cite this page

“Apotex Scientific, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto,.” GovInfoNow, recall dated January 26, 2016. https://govinfonow.com/recall/43209-apotex-scientific-inc-recalls-duloxetine-delayed-release-capsules-usp-60. Based on FDA recall #D-1436-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1436-2016%22&limit=1).

How to tell if you have this one

  • Brand
    Apotex Scientific, Inc
  • Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Nationwide, Alaska, Hawaii, and Puerto Rico.
Recall numberProduct, codes & lotsQuantity
D-1435-2016Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;; Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.107,880 (60 ct bottle)
D-1436-2016Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;; Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.605,989 (30 ct) bottles
D-1437-2016Duloxetine 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.; Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.750,273 (30 ct) bottles
Take action

Contact Apotex Scientific, Inc

We’ve drafted a message you can send Apotex Scientific, Inc to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-1436-2016 — Apotex Scientific, Inc Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, 

Hello,

I own a Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto that is covered by recall D-1436-2016 from Apotex Scientific, Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

Lupin Pharmaceuticals Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals,
Lupin Pharmaceuticals Inc. · 89% matchApotex Inc. recalls Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by
Apotex Inc. · 88% matchLupin Pharmaceuticals Inc. recalls Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,
Lupin Pharmaceuticals Inc. · 86% matchApotex Inc. recalls Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore-
Apotex Inc. · 86% matchApotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Apotex · 86% match

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1436-2016 (January 26, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1436-2016 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA