Dmso / Bupivacaine HCL 50%/0.5% Injectable recall: Sterility Concern
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO…
Why was Dmso / Bupivacaine HCL 50%/0.5% Injectable 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Rx #'s: 0368127 0368127 0396422 0394589 0389031 0397908 0405717 0377092 0395743 0399094 0364766 0377092 0383467 0395743 0399094 0385418 0377092 0391512 0397919 0409221 0395743 0383467 0410209 0353611 0397908 0409800 0372333 0381650 0388770 0357605 0399192 0357605 0357605 0399192 0357605 0370950 0384873 0389326 0357967 0399100 0356533 0361811 0368706 0392087 0401999 0402000 0402006 0405708 0408219 0361811 0368706 0371146 0379509 0380104 0384873 0393576 0403473 0405271 0405527 0371848 0388317 0399025 0408772 0398966 0398276 0352407 0371146 0375451 0377804 0383961 0384873 0388317 0391725 0392087 0393569 0396968 0371146 0375451 0368706 0399665 0401355 0402666 0407936 0362282 0388317 0368311
- Product
- DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 107 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)