Reported May 16, 2018 · Terminated
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
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 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
- Lot codes and dates
Lot NZ535Syringe Blaster Lot LP632AExp 6/30/2018 Lot PG631Syringe Blaster Lot MX842BExp 2/28/2019 Lot NP739Syringe Blaster Lot NE101BExp 3/31/2019 Lot PY818Syringe Blaster Lot PT888AExp 1/31/2020
- Amount recalled
- 1084
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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