Reported Aug 22, 2012 · Terminated

METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60…

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?

7 of 7 products

Products covered by this recall
#Product as published
1METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60 ML 80 ML 90 ML
2METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE 1 KIT 1 ML 10 ML 30 ML
3METHYLCOBALAMIN ( DR HALL KIT) PRESERVATIVE FREE 1,000MCG/ML INJECTABLE 1 KIT
4METHYLCOBALAMIN (PRESERV FREE) 1,000MCG/ML INJECTABLE 4 ML 8 ML
5METHYLCOBALAMIN (PRESERV FREE) 25,000MCG/ML INJECTABLE 1.5 ML 3 ML 3.5 ML 60 ML
6METHYLCOBALAMIN (PRESERVATIVE FREE) 25MG/ML INJECTABLE 30 ML 4 ML 8 ML
7METHYLCOBALAMIN 5,000MCG/ML INJECTABLE 6 ML (31 DIFFERENT PRODUCTS)
Lot codes and dates
  • Rx #'s:

    155 of 155 codes

    • 0391301
    • 0391927
    • 0397282
    • 0399470
    • 0391327
    • 0392711
    • 0394996
    • 0401004
    • 0395010
    • 0388696
    • 0389279
    • 0401772
    • 0402650
    • 0404045
    • 0404779
    • 0406029
    • 0408374
    • 0403432
    • 0392999
    • 0395958
    • 0396932
    • 0398177
    • 0405143
    • 0405968
    • 0407753
    • 0365101
    • 0365105
    • 0365106
    • 0365108
    • 0371252
    • 0371257
    • 0371265
    • 0371268
    • 0371270
    • 0382419
    • 0391063
    • 0391522
    • 0393199
    • 0403490
    • 0406625
    • 0406627
    • 0406630
    • 0409573
    • 0409579
    • 0409599
    • 0403432
    • 0387860
    • 0388243
    • 0389493
    • 0390022
    • 0390530
    • 0391010
    • 0391294
    • 0391645
    • 0392576
    • 0392665
    • 0392688
    • 0392894
    • 0393040
    • 0393092
Amount recalled
208 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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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 15, 2014 · Data as of Sep 19, 7:10 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.