CGMP Deviations: Product excipient was not re-tested at the appropriate date.
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
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.
We’ve drafted a message you can send Apotex Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0487-2015 — Apotex Inc. Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp. Hello, I own a Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, that is covered by recall D-0487-2015 from Apotex 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.
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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.
