Reported Aug 22, 2012 · Terminated
MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50%…
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
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: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML |
| 2 | MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML |
| 3 | MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML |
| 4 | MAGNESIUM SULFATE IN 5% DEXTROSE 4% (2GM/50ML) INJECTABLE 1200 ML |
| 5 | MAGNESIUM SULFATE, P.F. 50% (500MG/ML) INJECTABLE 180 ML 240 ML 4 ML 6 ML (14 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
035787103916340371936035251803719360390747037193603907470400018040032604081920402171040810104095030398622039978004017960401796038910904010030383611
- Rx #'s:
- Amount recalled
- 32 units
This recall covers 198 products
The agency filed one notice per product. You are reading one of them; the other 197 are below.
185 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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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