Reported Aug 22, 2012 · Terminated

HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS;…

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?

4 of 4 products

Products covered by this recall
#Product as published
1HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML
2HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS
3HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML
4HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCTS)
Lot codes and dates
  • Rx #'s: 0387947 0391167 0394583 0394583 0394579 0390379 0390379
Amount recalled
12 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 13, 2014 · Data as of Sep 19, 5:50 PM UTC

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