Class II · Moderate risk
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL
Lack of Assurance of Sterility
FDA Drug Recalls
90 recalls, newest first
Class II · Moderate risk
B-Complex (30 Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
BCAA (30 Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid 500 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Acid Recover Eaze
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Energy Cocktail
Lack of Assurance of Sterility
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Class II · Moderate risk
LGD-Xtreme
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Class I · High risk
Magnesium Sulfate Inj.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class III · Low risk
Quelicin (Succinylcholine Chloride)
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Class III · Low risk
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".