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Class II: temporary or reversible health riskTerminated

Franck's Lab Inc., d.b.a. Franck's Compounding Lab Morphine Sulfate 2mg/Ml Injectable 10 Ml Recall

MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML

Franck's Lab Inc., d.b.a. Franck's Compounding Lab · Ocala, FL

Risk level
Class II
Reported by FDA
Aug 22, 2012
Recall ID
D-1585-2012
Check your lot numberHow we source this data

Summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Morphine Sulfate 2mg/Ml Injectable 10 Ml starting May 21, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1585-2012 on Aug 22, 2012. Reason: 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. Status: Terminated.

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.

Product description

MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML; MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML; MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL 18 ML 20 ML 35 ML; MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL 18 ML (28 DIFFERENT PRODUCTS)

Lot numbers, UPCs & expiration codes

Rx #'s:N0396046 N0397450 N0404861 N0404320 N0389241 N0398238 N0408869 N0396836 N0390297 N0393345 N0393647 N0395395 N0397377 N0400800 N0403100 N0405536 N0408890 N0390024 N0391848 N0398239 N0403727 N0386864 N0388540 N0391192 N0391588 N0391831 N0391832 N0395396 N0396449 N0403824 N0403830 N0405260 N0405432 N0406253 N0407952 N0408884 N0393648 N0408194 N0394358 N0397366 N0397367 N0398708 N0398710 N0399636 N0400170 N0403098 N0405257 N0391608 N0401173 N0403253 N0405115 N0406436 N0390298 N0395170 N0407252 N0407520 N0392176 N0399300 N0406567 N0407428 N0387601 N0401757 N0388225 N0388588 N0392887 N0395240 N0398236 N0400870 N0404729 N0408213 N0399681 N0394427 N0388559 N0402004 N0386844 N0406159 N0390186 N0396640 N0404315 N0388587 N0402386 N0409165 N0389663 N0392048 N0387598 N0395522 N0396441 N0403779 N0405538 N0406915 N0399871 N0407182

Where it was sold

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1585-2012
Classification
Class II
Status
Terminated
Recall initiated
May 21, 2012
FDA report date
Aug 22, 2012
Quantity
92 units
Recall type
Voluntary: Firm initiated
Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Original FDA data

Every field from FDA enforcement report D-1585-2012, exactly as published.

Show all FDA fields
City
Ocala
State
FL
Status
Terminated
Country
United States
Event ID
62443
Address
1210 SW 33rd Avenue
Code information
Rx #'s:N0396046 N0397450 N0404861 N0404320 N0389241 N0398238 N0408869 N0396836 N0390297 N0393345 N0393647 N0395395 N0397377 N0400800 N0403100 N0405536 N0408890 N0390024 N0391848 N0398239 N0403727 N0386864 N0388540 N0391192 N0391588 N0391831 N0391832 N0395396 N0396449 N0403824 N0403830 N0405260 N0405432 N0406253 N0407952 N0408884 N0393648 N0408194 N0394358 N0397366 N0397367 N0398708 N0398710 N0399636 N0400170 N0403098 N0405257 N0391608 N0401173 N0403253 N0405115 N0406436 N0390298 N0395170 N0407252 N0407520 N0392176 N0399300 N0406567 N0407428 N0387601 N0401757 N0388225 N0388588 N0392887 N0395240 N0398236 N0400870 N0404729 N0408213 N0399681 N0394427 N0388559 N0402004 N0386844 N0406159 N0390186 N0396640 N0404315 N0388587 N0402386 N0409165 N0389663 N0392048 N0387598 N0395522 N0396441 N0403779 N0405538 N0406915 N0399871 N0407182
Postal code
34474-5138
Report date
Aug 22, 2012
Product type
Drugs
Recall number
D-1585-2012
Classification
Class II
Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Product quantity
92 units
Termination date
Aug 15, 2014
Reason for recall
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML; MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML; MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL 18 ML 20 ML 35 ML; MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL 18 ML (28 DIFFERENT PRODUCTS)
Distribution pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Recall initiation date
May 21, 2012
Initial firm notification
Letter
Center classification date
Aug 10, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1585-2012, published Aug 22, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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