Ameridose, a company connected to the New England Compounding Center (NECC), announced a recall of any unexpired products remaining in circulation. The recall is in response to an FDA notification that it will be seeking improvements in Ameridose’s sterility testing process. As of today, there are 386 cases of fungal infection (mostly spinal meningitis) linked to NECC methylprednisolone acetate, a steroid injected into the spine for back pain.
Ameridose stated in its announcement of the recall:
Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations.
The Ameridose medications recalled include the following in various amounts:
magnesium sulfate, dextrose
magnesium sulfate, sodium chloride
potassium chloride, sodium chloride (bag ans syringe)
potassium chloride, lactated ringers
potassium chloride, sodium chloride (bag and syringe)
potassium phosphate, dextrose
potassium phosphate, sodium chloride (bag and syringe)
sodium bicarbonate, dextrose
sodium bicarbonate syringe
potassium acetate, sodium chloride (bag and syringe)
calcium gluconate, sodium chloride
calcium gluconate, dextrose
calcium chloride, sodium chloride
phenylephrine, sodium chloride (bag and syringe)
ephedrine sulfate, sodium chloride syringe
lidocaine (buffered) syringe
lidocaine (preservative free) syringe
norepinephrine bitartrate, dextrose
amiodarone HCI, dextrose
diltiazem, dextrose
ondansetron HCI, sodium chloride
ondansetron HCI syringe
metoclopramide, sodium chloride
metoclopramide syringe
milrinone, dextrose syringe
vasopressin, dextrose
oxytocin, dextrose
oxytocin, sodium chloride
oxytocin syringe
diazepam oral syringe
morphine, sodium chloride syringe
morphine, buplvacaine, sodium chloride
morphine sulfate
morphine oral solution
lorazepam concentrated oral solution syringe
fentanyl intravia
fentanyl (PVC bag and syringe)
fentanyl, sodium chloride (bag and syringe)
methadone, sodium chloride syringe
methadone oral solution oral syringe
hydromorphone, sodium chloride (bag and syringe)
hydromorphone oral solution oral syringe
meperidine, sodium chloride (bag, pump bag and syringe)
meperidine HCI
meperidine oral syrup oral syringe
sufentanil, roplvacaine, epinephrine, sodium chloride
sufentaril, buplvacaine, epinephrine, sodium chloride
buplvacaine, sodium chloride (bag, pump bag and syringe)
roplvacaine, sodium chloride (bag, pump bag and syringe)
mepivacaine syringe
remifentanil for injection in a syringe
ketamine, sodium chloride syringe
fentanyl, bupivacaine (bag and syringe)
fentanyl, ropivacaine (bag and syringe)
methylprednisolone sodium succinate
succinylcholine chloride syringe
propofol syringe
dexamethasone sodium phosphate, sodium chloride
diazepam syringe
fentanyl, epinephrine,bupivacaine
heparin sodium, sodium chloride
heparin (preservative), sodium chloride syringe
midazolam (preservative free)
midazolam, dextrose syringe
midazolam HCI, sodium chloride
midazolam HCI, dextrose (bag and syringe)
midazolam oral syrup oral syringe
cefazolin in sterile water for injection in syringe
cefazolin sodium in sterile water for injection in syringe
vancomycin HCI, sodium chloride
vancomycin HCI, dextrose
vancomycin oral solution oral syringe
azithromycin, dextrose
clindamycin phosphate, dextrose
acyclovir, dextrose
ceftriaxone in sterile water for injection in a syringe
gentamicin, sodium chloride syringe
penicillin G Potassium, sodium chloride
heparin sodium (preservative), dextrose
heparin sodium (preservative), sodium chloride
heparin (preservative free) syringe
labetalol syringe
atrophine sulfate syringe
glycopyrrolate syringe
rocuronium syringe
vecuronium in sterile water for injection
cisatracurium syringe
neostigmine methylsulfate syringe
levetiracetam in sodium chloride bag
diphenhydramine in sodium chloride bag
promethazine in sodium chloride B.Braun bag
furosemide sodium chloride bag
furosemide syringe
furosemide dextrose bag
sodium phosphate in sodium chloride bag
haloperidol for injection in a syringe
dopamine dextrose in a syringe
sopaine dextrose bag
methohexital sodium for injection in a syringe
potassium chloride, sodium bicarbonate, dextrose in a lactated ringer bag
nalbuphine, sodium chloride bag
nalbuphine syringe
CWH-DF, sodium chloride, citrate sterile water for irrigation
magnesium sulfate, dextrose, sodium citrate, sodium chloride in sterile water for irrigation
magnesium sulfate, dextrose, sodium bicarbonate, sodium chloride in sterile water for irrigation
sodium bicarbonate added to to sterile water for injection
magnesium sulfate, potassium chloride, dextrose, sodium chloride bag
CWH sodium chloride, sodium citrate in sterile water for injection
sodium chloride intermate elastometric pump
sodium chloride for injection syringe
lorazepam syringe
lorazepam, dextrose in B. Braun bag
lorazepam, sodium chloride in B. Braun bag
lorazepam, sodium chloride in a glass PCA vial
acetaminophen injection repackaged in a monoject syringe
potassium phosphate, sodium chloride bag
sufentanil, sodium chloride syringe
sufentanil syringe
sodium citrate syringe
ketamine oral solution in syringe
potassium chloride, potassium phosphate, sodium chloride, dextrose bag
potassium chloride, potassium phosphate, sodium chloride in sterile water for injection
dextrose for injection in a syringe
ephedrine sulphate, sodium chloride syringe
magnesium sulfate, sodium chloride
oxycodone oral solution repackaged in an oral syringe
magnesium sulfate, sodium chloride
magnesium sulfate, dextrose
magnesium sulfate lactated ringers
magnesium sulfate in sterile water for injection
potassium chloride, lidocaine, sodium chloride
potassium chloride, sodium chloride syringe
potassium chloride, dextrose and lactated ringers
potassium chloride, dextrose
potassium phosphate, dextrose
potassium phosphate, sodium chloride,
sodium bicarbonate, sodium chloride
sodium bicarbonate, dextrose
calcium gluconate, sodium chloride
calcium chloride, sodium chloride
phenylephrine, dextrose
phenylephrine, sodium chloride
phenylephrine, sodium chloride syringe
ephedrine, sodium chloride (bag and syringe)
lidocaine syringe
norepinephrine bitartrate, sodium chloride (bag and syringe)
amiodarone, dextrose
oxytocin, sodium chloride
fentanyl, sodium chloride (bag, syringe, vial)
hydromorphone, buplvacaine, sodium chloride
hydromorphone, dextrose
hydromorphone, sodium chloride (bag and syringe)
morphone sulfate, sodium chloride
morphine oral solution repackaged in an oral syringe
morphine, dextrose
mederidine, sodium chloride
sufentanil, roplvacaine, sodium chloride
buplvacaine, sodium chloride pump
roplvacaine, sodium chloride (bag, cassette and smart book)
ketamine, sodium chloride
ketamine in sterile water for injection in a syringe
ketamine syringe
fentanyl, buplvacaine, sodium chloride (bag, cassette, pump bag and syringe)
fentanyl, roplvacaine, sodium chloride (bag, pump bag, syringe)
succinylcholine chloride syringe
heparin sodium, dextrose
midazolam, sodium chloride (bag and syringe)
midazolam oral syrup repackaged in an oral syringe,
cefazolin in sterile water for injection
vancomycin, sodium chloride
vancomycin, dextrose (bag and syringe)
clindamycin in sterile water for injection
heparin sodium, dextrose
heparin sodium, sodium chloride
heparin, sodium chloride (bag and syringe)
labetalol syringe
labetalol, dextrose
atropine sulfate syringe
vecuronium syringe
furosemide in dextrose
sodium phosphate, sodium chlorine
sodium phosphate, dextrose
dopamine, dextrose (bag and syringe)
potassium chloride oral solution syringe
sodium chloride intermate elastometric pump
postassium phosphate, dextrose
hydrocodone bitartrate, homatropine methlbromide oral syringe
oxycodone oral solution oral syringe
phenylephrine, sodium chloride syringe
ephedrine, sodium chloride syringe
norepinephrine, dextrose syringe
phenobarbital oral solution syringe
midazolam oral syrup oral syringe
cefepime in sterile water for injection in syringe
clindamycin in sterile water for injection in syringe
ceftriaxone in sterile water for ingection in a syringe
furosemide, dextrose
furosemide, sodium chloride
opium oral solution repackaged in oral syringe
pentobarbital repackaged in syringe
famotidine, sodium chloride syringe
dexmedetomidine, sodium chloride
remifentanil in sterile water for injection
acetaminophen with codine oral syringe
acetaminophen oral suspension oral syringe
acetylcysteine inhalation solution oral syringe
cetirizine oral syrup oral syringe
diazepam oral solution oral syringe
ferrous sulfate oral solution oral syringe
ibuprofin oral suspension oral syringe
metoclopramide oral solution oral syringe
midazolam oral syrup oral syringe
polyvitamin oral solution oral syringe
multivitamin oral solution oral syringe
polyvitamin with iron oral solution oral syringe
mulivitamin with minerals oral solution oral syringe
nystatin oral suspension oral syringe
ondansetron oral solution oral syringe
potassuim chloride oral solution oral syringe
prednisolone sodium phosphate oral solution oral syringe
rantidine oral syrup oral syringe
sodium chloride oral syringe
hydrocodone, acetaminophen oral syringe
promethazine with codeine oral syringe
hydrocodone, chlorpheniramine, polistirex oral suspension oral syringe
