Reported May 16, 2018 · Terminated
Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Straumann Manufacturing, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann Manufacturing, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
- Lot codes and dates
Lot NP737Syringe Blister Lot NA438AExp 3/31/2019Lot PG628Syringe Blister Lot NF819AExp 3/31/2019Lot PY816Syringe Blister Lot PT888CExp 1/31/2020Lot NY939Syringe Blister LotNA438AExp 3/31/2019
- Amount recalled
- 2381
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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