Reported Aug 22, 2012 · Terminated
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL…
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 | ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET |
| 2 | ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET |
| 3 | ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML |
| 4 | ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML |
| 5 | ESTRADIOL VALERATE IN SESAME OIL 40 MG/ML INJECTABLE 10 ML (16 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
70 of 70 codes
038946403988330399748040291704029260405892040407904040860392875039806704031370403795040450604086940404895038749203898130390461039126403918180391961039295203937660395543039623203969250397181039731303979590399219040022704007490400845040149704019980402465040299704031620405298040533004053410406903040741904080210409309040979104024060402414038998203899760407175038610103917820394584039957604031540403358040479504065320409701
- Rx #'s:
- Amount recalled
- 72 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 because 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.
Want the full recall guide?
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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