Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
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 Hi-Tech Pharmacal Co., Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-302-2013 — Hi-Tech Pharmacal Co., Inc. Hi-Tech Pharmacal Co., Inc. recalls Acetic Acid Otic Solution, USP, 15 m Hello, I own a Hi-Tech Pharmacal Co., Inc. recalls Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC that is covered by recall D-302-2013 from Hi-Tech Pharmacal Co., 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.
