Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Recall notice
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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Source Page by GovInfoNow · govinfonow.com/recall/39832-akorn-inc-recalls-lidocaine-2-5-and-prilocaine-cream-2 · Recall date August 1, 2018 · FDA enforcement record: FDA #D-1046-2018
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“Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,.” GovInfoNow, recall dated August 1, 2018. https://govinfonow.com/recall/39832-akorn-inc-recalls-lidocaine-2-5-and-prilocaine-cream-2. Based on FDA recall #D-1046-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2018%22&limit=1).
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We’ve drafted a message you can send Akorn, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1046-2018 — Akorn, Inc. Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manuf Hello, I own a Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, that is covered by recall D-1046-2018 from Akorn, 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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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-1046-2018 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1046-2018 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.