Reported Aug 22, 2012 · Terminated
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE…
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?
- NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE DECANOATE 300MG/ML INJECTABLE 10 ML 30 ML (6 DIFFERENT PRODUCTS)
- Lot codes and dates
- Rx #'s:
145 of 145 codes
C0371167C0371185C0371187C0371193C0381331C0381336C0381348C0381353C0381360C0381364C0381366C0381371C0384632C0384634C0384637C0389199C0389200C0389201C0389205C0389216C0389219C0389223C0389224C0392398C0392399C0392401C0392405C0392407C0392409C0392410C0392411C0392412C0392414C0392418C0392419C0392421C0392426C0392429C0392433C0392434C0392435C0392436C0392438C0392441C0394169C0394170C0394171C0394172C0394173C0394174C0394175C0394176C0394177C0394178C0394179C0394180C0396357C0396362C0396365C0396370
- Rx #'s:
- Amount recalled
- 160 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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