Straumann recalls Emdogain 0.7ml Multipack (Article 075.115) due to unapproved shelf life change in raw materials. Affected lots expire 6/30/2018 to 3/31/2019. No remedy specified in recall notice.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Straumann is recalling Emdogain 0.7ml Multipacks (Article 075.115) because a raw material's shelf life was changed without proper testing. This could affect product effectiveness over time, though no immediate safety risk is described in the recall.
The recall states that a raw material's shelf life was changed without proper data showing the product still works effectively. This could mean the medication becomes less effective over time, but the recall does not mention safety risks like injury or illness.
Patients using Emdogain for gum disease treatment who purchased the recalled multipacks between 2018 and 2019 are most at risk. The product is used for medical purposes under professional guidance.
Check for the product name 'Emdogain 0.7 ml Multipack USA' with Article Number 075.115. Look for specific lot numbers listed in the recall: LZ713 through NP345, with expiration dates from June 2018 to March 2019.
Identify the product by checking the Article Number 075.115 and lot numbers listed in the recall notice.
The recall states the product may become less effective over time due to a raw material shelf life change, but no safety risks like injury are mentioned.
The recall does not specify a remedy, so no action is required beyond checking if you have the recalled lot numbers.
Check for the product name 'Emdogain 0.7 ml Multipack USA' with Article Number 075.115 and lot numbers from LZ713 to NP345 as listed in the recall.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2018 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1697-2018 from Straumann. 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.
