Reported May 16, 2018 · Terminated
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
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 USA. Enamel Matrix Derivative. Article Number 075.115
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 Lot LZ713, Syringe Blaster 2 Lot LP632B, Exp 6/30/2018 3 Lot MZ542, Syringe Blaster 4 Lot LP632B, Exp 6/30/2018 5 Lot MG933, Syringe Blaster 6 Lot LP632B, Exp 6/30/2018 7 Lot MZ543, Syringe Blaster 8 Lot MG253C, Exp 9/30/2018 9 Lot NJ581, Syringe Blaster 10 Lot MG253C, Exp 9/30/2018 11 Lot NJ582, Syringe Blaster 12 Lot NA438B, Exp 3/31/2019 13 Lot NP345, Syringe Blaster 14 Lot NE101B, Exp 3/31/2019 - Amount recalled
- 2356
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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