GMP Deviations: A silicone particulate was noted in Ozurdex.
Prescription Drugs
💊 Drugs • 11,927 recalls
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Subpotent
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Methocarbamol liquid 100mg/ml, RX, glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Lidocaine gel 2%, RX, plastic dropper
Hiers Enterprises, LLC
Lack of sterility assurance.
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Glutathione liquid, 200mg/ml, Rx
Hiers Enterprises, LLC
Lack of sterility assurance.
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Lidocaine gel 1%, RX, plastic dropper
Hiers Enterprises, LLC
Lack of sterility assurance.
HCG liquid, 1000u/ml, RX, glass vial, various
Hiers Enterprises, LLC
Lack of sterility assurance.
Testosteron Cypionate liquid 200mg/ml, RX, glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Hiers Enterprises, LLC
Lack of sterility assurance.
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Hiers Enterprises, LLC
Lack of sterility assurance.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
Hiers Enterprises, LLC
Lack of sterility assurance.
Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
Hiers Enterprises, LLC
Lack of sterility assurance.
Epinephrine liquid 1:1000, RX, glass vial
Hiers Enterprises, LLC
Lack of sterility assurance.
Cyclosporin liquid 1%, Rx, plastic dropper bottle
Hiers Enterprises, LLC
Lack of sterility assurance.