Reported Aug 22, 2012 · Terminated
PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN…
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 | PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML |
| 2 | PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML |
| 3 | PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML |
| 4 | PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML |
| 5 | PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s: 0404389 0405327 0369106 0398391 0389137 0399520
- Amount recalled
- 8 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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