Class II · Moderate risk Terminated
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
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Class II · Moderate risk Terminated
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to…
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Sucralfate Oral Suspension
Reason Labeling: Label Mix-Up
Class III · Low risk Terminated
Risedronate Sodium Tablets
Reason FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class II · Moderate risk Terminated
Rock Town - Distillery - Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class I · High risk Terminated
Meclizine Hydrochloride Tablets USP
Reason Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Reason Super Potent and Failed Reconstitution Time
Class III · Low risk Terminated
Hydroxocobalamin B12 1mg/mL
Reason Sub Potent
Class III · Low risk Terminated
Sb-4
Reason Sub Potent
Class III · Low risk Terminated
T-105
Reason Super Potent
Class III · Low risk Terminated
Formula F9
Reason Sub Potent
Class II · Moderate risk Terminated
NAD+ Nicotinamide Adenine Dinucleotide
Reason Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk Terminated
Sermorelin Acetate Lyophilized powder for reconstitution
Reason Sub Potent
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class I · High risk Terminated
Sodium Acetate Injection
Reason Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class II · Moderate risk Terminated
Alprazolam C-IV 2 mg
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk Terminated
Alprazolam C-IV 1 mg 60-count bottles
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk Terminated
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.