Reported Aug 22, 2012 · Terminated
PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML |
| 2 | PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML |
| 3 | PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
04072450405512039057304018160391676039223403880240405512039167603627420362742
- Rx #'s:
- Amount recalled
- 16 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.
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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