MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML ...
FDA Drug Recall #D-1585-2012 — Class II — May 21, 2012
Recall Summary
| Recall Number | D-1585-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 21, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| Location | Ocala, FL |
| Product Type | Drugs |
| Quantity | 92 units |
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)
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.
Distribution Pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Lot / 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
Other Recalls from Franck's Lab Inc., d.b.a. Franck's Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1513-2012 | Class II | ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PR... | May 25, 2012 |
| D-1452-2012 | Class II | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, ... | May 25, 2012 |
| D-1514-2012 | Class II | EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJ... | May 25, 2012 |
| D-1451-2012 | Class II | AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16"... | May 25, 2012 |
| D-1492-2012 | Class II | CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%... | May 25, 2012 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.