Reported Aug 22, 2012 · Terminated
ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML;…
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?
17 of 17 products
| # | Product as published |
|---|---|
| 1 | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML |
| 2 | ALPROSTADIL 15MCG/ML INJECTABLE 5 ML |
| 3 | ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML |
| 4 | ALPROSTADIL 24MCG/ML INJECTABLE 6 ML |
| 5 | ALPROSTADIL 25MCG/ML INJECTABLE 10 ML |
| 6 | ALPROSTADIL 30MCG/ML INJECTABLE 10 ML |
| 7 | ALPROSTADIL 35MCG/ML INJECTABLE 10 ML |
| 8 | ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML |
| 9 | ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML |
| 10 | ALPROSTADIL 60MCG/ML INJECTABLE 20 ML |
| 11 | ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML |
| 12 | ALPROSTADIL 100MCG/ML INJECTABLE 5 ML |
| 13 | ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML |
| 14 | ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE |
| 15 | ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML |
| 16 | ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML |
| 17 | ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS) |
- Lot codes and dates
436 of 436 codes
Rx #'s: 035824603648050368284037875603808200387648038817503882940388761039137003932180393296039434903949460395082039586103961870398267040131904042910405612038818603990340386335040043104075310358246037875603887430400047040436303880820409372034845503506630353518035512903556930356375035747003576160358082035824403584340359158036328503652590367960036960103708440370856037160003723640373144037337503735100374111037499803754590375602
- Amount recalled
- 529 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.
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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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