CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Morphine Sulfate 2mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Morphine Sulfate 2mg/ML Injectable, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1585-2012
- FDA event ID
- 62443
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 21 May 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +81 days |
| 22 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Questions about this recall
Is Morphine Sulfate 2mg/ML Injectable recalled?
Yes. Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Morphine Sulfate 2mg/ML Injectable on 21 May 2012. The recall is Class II and its status is Terminated. Recall number D-1585-2012.
Why was it 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.
Which lots are affected?
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 was it sold?
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.