Reported May 29, 2019 · Terminated
Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose…
Remel 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: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519
Is this the product you have?
- Thio Med w/o Ind
- w/Dex (9ml) 20/PK Product UsageRecommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- Lot codes and dates
- Material NumberR064702
- Lot Number (Labeled Expiration Date)
303274 (11/29/2018)327634 (01/15/2019)359077 (03/18/2019)379729 (04/25/2019)391553 (05/20/2019). Expansion
- Lot Number (Labeled Expiration Date)423547 (07/30/2019)
- Amount recalled
- 736 units
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
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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