Class II · Moderate risk Terminated
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
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Class II · Moderate risk Terminated
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON…
Reason Subpotent drug.
Class II · Moderate risk Terminated
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only…
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON…
Reason Subpotent drug.
Class II · Moderate risk Terminated
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
Class I · High risk Terminated
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk Terminated
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial…
Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class II · Moderate risk Terminated
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research…
Reason Failed Stability Specifications: product may not meet specification limit for assay test.
Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC…
Reason Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk Terminated
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only…
Reason Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class II · Moderate risk Terminated
Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo…
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during…
Class II · Moderate risk Terminated
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured…
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during…
Class II · Moderate risk Terminated
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard…
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during…
Class II · Moderate risk Terminated
Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard…
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during…
Class III · Low risk Terminated
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By…
Reason Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.