Class II · Moderate risk Completed
Sterile Diluent
Reason CGMP Deviations
Insulin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
What was recalled
INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1547-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Insulin recalls
See all
Class II · Moderate risk Ongoing
Admelog
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label on the vial
Class I · High risk Completed
Humalog KwikPen
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
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